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RESUSCITATION2020 the Virtual Congress

RESUSCITATION2020 the Virtual Congress

The European Resuscitation Council (ERC) will transform its RESUSCITATION2020 congress into a virtual event during which you will have the opportunity to interact with resuscitation experts, to share your scientific work, to present your top-notch performance in the resuscitation competition and to get in touch with our partners and each other in digital meeting rooms.

RESUSCITATION2020 will take place on a custom ERC digital platform. More information will be released on this website. 

Make sure to have your spot available for this unique event.


Published: 21st September 2020

Source: RESUSCITATION2020

Page URL: http://www.resuscitation2020.eu/en/home?utm_source=resuscounciluk_medium=li_date=210920

List of Customs Agents and Fast Parcel Operators from 1st January 2021

List of Customs Agents and Fast Parcel Operators from 1st January 2021

Find customs agents and fast parcel operators who can help submit customs declarations from 1 January 2021.

Office for Life Sciences Bulletin – 18th September 2020

Office for Life Sciences Bulletin – 18th September 2020

The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS).
This bulletin aims to keep the life sciences sector up to date on the latest guidance whilst the UK is in the transition period and during the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks prepare.


Published: 18th September 2020

Source: Office for Life SciencesGOV UK

STOP THE PRESSURE – Tissue Viability Society

STOP THE PRESSURE – Tissue Viability Society

On Thursday 19th November 2020 the Tissue Viability Society have one goal worldwide: STOP PRESSURE ULCERS

STOP Pressure Ulcer Day is a global annual event in which industry, healthcare professionals, the  public and media come together to help raise awareness of pressure ulcers – something many people are touched by every year. In 2012, the Declaration in Rio was created in which Spanish-speaking countries (the first to hold STOP Pressure Ulcer Days) spoke out against people developing pressure ulcers. The aim of this annual event, which now takes place in countries all over the world, is to increase public knowledge in a bid to prevent pressure ulcers from forming and affecting so many people each year.

The Tissue Viability Society along with their Corporate Sponsors and other industry partners would like to support Healthcare Professionals to take part in the International Stop Pressure Ulcer Campaign.

We have started to collate some useful materials within our Online Resource Centre, to help you plan your event, along with other materials which you may find helpful.

Click Here to find out more.


Published: 18th September 2020

Source: Tissue Viability Society

Page URL: https://tvs.org.uk/stop-pressure/

TVS 2021 – The Conference

TVS 2021 – The Conference

TVS 2021 – The Conference

“We are delighted to announce that TVS 2021 – The Conference will be held in Glasgow on the 22-23 September in collaboration with the NATVNS.

Our venue is Hampden Park which is located 5 minutes from Junction 1a of the M74. With ample free parking and state-of-the-art function rooms, the venue is ideal for our annual conference.

The Conference agenda will be packed with a wealth of fascinating talks on hot topics from key local, national and international opinion leaders.

NMC Revalidation

Attending TVS 2021 – The Conference counts towards your participatory learning. Click here for more information on NMC Validation.

And finally…

Over the coming months, pages will be added to provide you with all the information that you will need when planning your participation, although this does not replace our personal service. If you need any advice or assistance, do not hesitate to contact a member of the organising team.

Please click here to register to receive our regular updates

So please save the date for what promises to be our best conference yet! We hope to welcome you in Glasgow.”

Linda Primmer, TVS Chair of Trustees
Jeannie Donnelly, TVS Vice Chair of Trustees


Published: 17th September 2020

Source: Tissue Viability Society

Page URL: https://tvs.org.uk/tvs-2021-the-conference/

CMA’s Updated Guide for Businesses on Compliance to Competition Law

CMA’s Updated Guide for Businesses on Compliance to Competition Law

The CMA has updated its guide for businesses on how to comply with competition law:

The pdf below provides a basic overview of competition law, outlining the steps businesses and risk professionals can take to help identify and reduce competition law risks. It also outlines what to do if competition law has been breached and provides case studies with key learnings.

For further detailed information Click Here – https://www.gov.uk/government/publications/competition-law-risk-a-short-guide/competition-law-risk-a-short-guide


Published: 17th September

Letters to Businesses about New Trade Arrangements with the EU from 1st January 2021

Letters to Businesses about New Trade Arrangements with the EU from 1st January 2021

HMRC letters to VAT-registered businesses in Great Britain trading with the EU and/or the rest of the world, highlighting actions they need to take to continue trading with the EU from 1 January 2021.


This information applies to: Wales, England, and Scotland

These letters have been sent to VAT-registered businesses in Great Britain trading with the EU, or the EU and the rest of the world.

They explain what businesses need to do to prepare for new processes for moving goods between Great Britain and the EU from 1 January 2021, including:

  • making sure they have a UK Economic Operator Registration and Identification (EORI) number
  • deciding how they will make customs declarations
  • checking if their imported goods are eligible for staged import controls

These actions will not change regardless of the outcome of the government’s negotiations with the EU. Businesses can keep up to date with these changes by registering for HMRC’s email updates.


Published: 14th September 2020

Source: GOV UK, HM Revenue & Customs

Page URL: https://www.gov.uk/government/publications/letters-to-businesses-about-new-trade-arrangements-with-the-eu-from-1-january-2021?utm_source=59324bea-5bc7-439a-b71a-3325d4a096d6&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Coronavirus Outbreak FAQs: What you can and can’t do

Coronavirus Outbreak FAQs: What you can and can’t do

This is national guidance that applies to England only – people in ScotlandWales and Northern Ireland should follow the specific rules in those parts of the UK. If you live in an area that is experiencing a local COVID-19 outbreak and where local restrictions have been imposed, different guidance and legislation will apply. Please consult the local restrictions page to see if any restrictions are in place in your area.

Office for Life Sciences Bulletin – 11th September 2020

Office for Life Sciences Bulletin – 11th September 2020

The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS).
This bulletin aims to keep the life sciences sector up to date on the latest guidance whilst the UK is in the transition period and during the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks prepare.


Published: 11th September 2020

Source: Office for Life SciencesGOV UK

Page URL: https://www.gov.uk/government/publications/letters-to-businesses-about-new-trade-arrangements-with-the-eu-from-1-january-2021?utm_source=59324bea-5bc7-439a-b71a-3325d4a096d6&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Customs, VAT and Excise UK Transition Legislation from 1st January 2021

Customs, VAT and Excise UK Transition Legislation from 1st January 2021

This collection brings together Customs, VAT and Excise EU Exit legislation and Customs notices that have the force of law applicable to UK transition.

Beds and Support Surfaces & Seating and Positioning Section – 9th September 2020

Beds and Support Surfaces & Seating and Positioning Section – 9th September 2020

Everyone at the NWCSP (National Wound Care Strategy Programme) has been very busy during the COVID-19 pandemic, working on ways to standardise wound care, maximise positive outcomes and support healthcare colleagues.
As the summer of 2020 draws to a close, they would like to share their progress:


Published: 9th September 2020

Source: NWCSP

Government Reaches Deals with US-based Company to Deliver 250,000 Clear Face Masks

Government Reaches Deals with US-based Company to Deliver 250,000 Clear Face Masks

A quarter of a million clear face masks are to be delivered to NHS and social care workers on the frontline to support those who use lip-reading and facial expressions to communicate.

Common Scams Targeting Seniors and how to Avoid Them

Common Scams Targeting Seniors and how to Avoid Them

Seniors face all of the same scams as everyone else, but some scams disproportionately affect the older generations. Many of these fall under the umbrella of elder fraud – the misappropriation or abuse of financial control in a relationship where there is an expectation of trust, resulting in harm to a senior victim.

Elder fraud is vastly underreported, according to a study by Comparitech. The study estimates 5 million cases of elder fraud occur in the US alone each year, resulting in $27.4 billion in losses. This means that 38 percent of fraud cases target the elderly.

But what makes older people susceptible to fraud? What sorts of scams target seniors, and what can seniors do to avoid these scams?

Elderly People Are Attractive Targets for Scammers

A number of factors contribute to senior people’s susceptibility to certain types of fraud, including:

Social Isolation

Many seniors don’t have close friends or family they can talk to about day-to-day life. This can make them more willing to continue a conversation with a potential scammer. They might not have anyone to run things by to get a second opinion. And if they fall victim to a scam, they are less likely to tell anyone about it.

Good Credit and Lots of Money

Older people have six times as much cash as younger people on average and often have strong, well-established credit scores. This makes them enticing targets for criminals.

Lack of Cybersecurity Awareness

Seniors didn’t grow up with smartphones and the Internet and tend to be less active online. As the technological world continues to advance at a rapid clip, it can be tough for seniors to learn and keep up with digital hygiene.

Common Problems

Many seniors face similar issues: health concerns, retirement security, caring for loved ones, and loneliness. Scammers can craft their messages to address these issues while still casting a wide net to lure in a large number of potential victims.

Scams Targeting Older Adults

Urgency is a common thread in almost all scams.

Scammers try to instill a sense of urgency in their victims. They will create some sort of deadline in order to make you rush to a decision. They do this because it works; people who react without thinking things through tend to make mistakes.

So, if you feel rushed to make any move involving money or private information, stop. Take a breath. Take in what is happening and analyze the situation. Do not let others make decisions for you.

Keep that in mind as you read through some of these types of scams. It’s easy to fool yourself into thinking you would never fall for such obvious ploys, but when in a hurry, we all tend to let our guard down.

Below we describe the types of scams that usually target seniors:

Advance Fee Scams

Advance fee scams take many forms but follow a simple pattern: scammers ask for an up-front payment in return for a greater reward down the road.

Common advance fee scams that target seniors include:

Investment Scams

Many seniors have money to invest but, grimly, not a lot of time to wait for investments to mature. Because of this, they tend to be drawn to short-term investments, which is where fraudsters focus their efforts.

Lottery and Sweepstakes Scams

In the usual scenario, the scammer claims that the victim has won a large sum of money, but a smaller amount has to be paid in order to claim it. Scammers tell victims the fee is meant to cover transfer fees or taxes, for example.

Inheritance Scams

The scammer will tell you someone has died, and you are entitled to some amount of money according to their will, but you must first pay a fee to release the funds.

The sunk cost fallacy plays a strong role in advanced fee scams, as victims continue to give money in the hopes that their initial investment was a wise one.

In reality, all of the money is pocketed by scammers.

How to Spot Advance Fee Scams

There are a few ways to spot and avoid advance fee scams.

First of all, any investments you make should be proactive, not reactive. You should actively seek out investments based on your own research, and avoid giving into sales pitches from solicitors approaching you with “opportunities.”

If you didn’t enter a lottery, it’s safe to say you can’t win it.

Scammers will often ask for odd forms of payment, such as cryptocurrencies, wire transfers, and gift cards.

Grandparent Scams

This scam often occurs over the phone though email and social media are also used.

The scammer calls a senior person, posing as their grandchild. They will complain about being in some sort of emergency situation, and ask that money be sent quickly to help them out of a jam. They might ask for bail money or airfare to get home, for example.

How to Avoid Grandparent Scams

If you’re uncertain as to whether the caller is actually your grandchild or not, take steps to verify their identity. The caller might try to avoid questions by claiming that they don’t have time to answer them. This is a ploy to make you feel rushed and careless.

Be sure to ask questions that can’t be found online. Asking the supposed grandchild for their parents’ names is too easy. Scammers will have such information ready at their disposal. Instead, ask specific questions that only a grandchild would know.

Also, be wary of how they demand payment. Scammers will usually want something that’s difficult to trace or take back. Wire transfers, cryptocurrency, gift cards, and other seemingly odd forms of payment should raise red flags.

Tech Support Scams

Tech support scams take place over the phone and online. Scammers call or message their target posing as Microsoft or another tech company. They will claim that your computer is broken or infected with a virus, and that they must follow their orders to fix it.

They may also tell you that failing to fix the computer will result in lost data, stolen funds, computer damage, or even police intervention.

From there, scammers can try a number of schemes. They may claim to have “fixed” your computer and ask for a fee. They might trick you into installing remote control software or malware so they can hijack your device later.

Or they might instruct you to log into your bank account to test for banking malware when they’re really just stealing your bank account information.

How to Spot Tech Support Scams

Microsoft and other tech companies will not proactively contact you about your computer problems. If you have a computer problem, you must contact them. So, if someone calls or messages you claiming to be some sort of technician, it’s likely a scam.

Identity Theft

Identity theft involves a scammer using your personal information to pose as you in order to reap some financial benefit. They may take out loans, obtain your medical prescriptions, or sign up for services under your name.

When it comes to elder fraud, most identity theft is perpetrated by someone close to the victim, such as a family member or caregiver.

How to Spot Identity Theft

Keep an eye on your bank statements and credit reports. If you see anything suspicious, follow up on it. If you start receiving bills or getting calls from debt collectors that you don’t recognize, that can be a sign of identity theft.

Be sure to keep important documents like your Social Security card in a locked and hidden place. Shred any documents containing personal information before you discard them.

Romance Scams

Romance scams prey on seniors who feel isolated and are looking for companionship. These scams most often start online and heavily target women over 50. They usually take place on dating apps or social media.

The scammer poses as a potential love interest and, over time, earns their victim’s trust. Once the victim has been sufficiently groomed, the scammer tests them by asking for money.

It will be a small amount at first. The scammer may say the money is to help a relative, fix their car, or buy their child a birthday present.

From there, the situation escalates.

The scammer might ask for compromising photos or information that they can later use to extort their victim. They start asking for larger amounts of money, piling on excuses as to why they need it. Sometimes scammers ask victims to receive and send packages on their behalf, turning victims into mules.

How to Recognise Romance Scams

The scammer will make all sorts of excuses as to why they can’t meet you in person. They often claim to be in the military or work in other jobs that require frequent travel.

Use a reverse image search to look up suitors’ profile images. Fraudsters often steal photos from real people to use in their scam profiles.

Scammers often work in groups but pose as a single person, so if you notice inconsistencies in tone, grammar, or use of emoticons, that’s a red flag.

Try arranging a video call with the suitor. Scammers will make some excuse, such as a broken camera.

Time is money, so scammers will often shower victims with affection and compliments. “Love bombing” is intended to get victims’ trust up quickly so they will send money sooner.

Never send money, private information, or compromising photos to someone who asks for them before you’ve met in person.

Tax Scams

Tax scams take many forms. They usually involve the scammer posing as the IRS. Some of these scams include:

  • Fraudsters claiming you owe a tax debt that must be paid immediately to avoid arrest.
  • Scammers filing taxes in your name and requesting a much larger refund than you’re owed. When you receive that refund, scammers call you and demand it be paid back.
  • Fraudsters claiming you have a pending refund and you can claim it at a website that is actually run by the scammers. This website asks for information that can be used for identity theft, such as your Social Security number.

How to Spot and Avoid Tax Scams

File taxes early so no one else can do it in your name.

If a caller requests payment in a specific form, such as a wire transfer, it’s probably a scam. Most tax agencies allow multiple forms of payment.

Know that the HMRC (UK), will not ask for information over email and usually won’t initiate contact over the phone. They will either send snail mail or an email alert letting you know that you have a new message that can be read by logging into your official online account.

Health Scams

Health scams usually take place online and can be extremely dangerous for victims. Here are a few examples of health scams:

  • Counterfeit and expired drugs sold on online pharmacies.
  • Promises of free medical equipment that is then billed to you or your insurance.
  • Fraudulent treatments, often associated with anti-aging or other current health threats.

How to Avoid Health Scams

Be wary of online pharmacies and other online vendors for medical treatments and equipment. No legitimate online pharmacy will send you emails or call your home if you’re not already a customer.

Never buy from a pharmacy that sells prescription drugs without a doctor’s prescription. Filling out an online questionnaire is not enough to get a prescription.

Never sign blank insurance claim forms or give blanket authorization to a medical provider. Don’t trust online, door-to-door, or over-the-phone salespeople.

Don’t Underestimate Scammers

Many people, elderly included, tend to underestimate scammers. It’s not that their tactics are particularly effective. Most people reading this have spotted and avoided scams before. Instead, people underestimate the persistence of scammers and frequency of these schemes.

Many scams – particularly those on the Internet – are cheap to operate and easy to pull off, and can be carried out without consequence to the scammer even if they are caught.

These factors allow scammers to brazenly target a lot of people in a short span of time, and they only need a tiny fraction of targets to fall victim in order to make a return on their investment.

What do you know about scams? Have you been a target of a scam? Did you recognise it as such? Did you tell anybody about it? Have you fallen victim to a scam? What made you trust the scammer? What advice do you have for others in a similar situation? Please share your thoughts and stories so no woman in our community will feel unprotected from scams.


Published: 8th September 2020

Source: Sixty and Me

Page URL: https://sixtyandme.com/seniors-scams/

Using QR Codes for Venues via the NHS Test and Trace App

Using QR Codes for Venues via the NHS Test and Trace App

Office for Life Sciences would welcome your feedback on the guidance that has been published to date so that we can
work with colleagues across Government to ensure that the information is as comprehensive and clear as possible.

Introducing the NHS Test and Trace App:


Business Guidance:


Consumer Guidance:


Published: 7th September 2020

Source: Office for Life Sciences

Office for Life Sciences Bulletin – 4th September 2020

Office for Life Sciences Bulletin – 4th September 2020

The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS).
This bulletin aims to keep the life sciences sector up to date on the latest guidance whilst the UK is in the transition period and during the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks prepare.

Click Here to find out more on Using QR Codes for Venues via the NHS Test and Trace App


Published: 4th September 2020

Source: Office for Life SciencesGOV UK

Passport Rules for Travel to Europe from 1st January 2021

Passport Rules for Travel to Europe from 1st January 2021

Advice for British passport holders from January 2021.

Until 1 January 2021, you can continue to travel to Europe with your UK passport until it expires.

New rules will apply for travel to Europe from 1 January 2021.

If your passport is burgundy or has ‘European Union’ on the cover, you can continue to use it until it expires.

You’ll need to have at least 6 months left on an adult or child passport to travel to most countries in Europe (not including Ireland).

If you renewed your current passport before the previous one expired, extra months may have been added to its expiry date. Any extra months on your passport over 10 years may not count towards the 6 months needed.

Check whether you need to renew your passport before travelling to Europe from 1 January 2021

You’ll need to renew your passport before travelling if you do not have enough time left on your passport.

Sign up for email updates on GOV.UK.

List of countries affected

The new rules will apply for travel to and between most countries in Europe. These are:

  • Andorra
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Monaco
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • San Marino
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • Vatican City
Travel to other EU countries

The new rules will not apply when travelling to Ireland.

Applying for a new passport

If your passport doesn’t meet the new rules, you will need to apply for a new passport before travelling to the countries affected.

Do not book travel unless your passport meets the entry requirements of the country you’re travelling to.

Make sure you apply in plenty of time. If you need to, you can apply to get a passport urgently.


Published: 4th September 2020

Source: GOV UK, HM Passport Office

Page URL: https://www.gov.uk/guidance/passport-rules-for-travel-to-europe-after-brexit?utm_source=07d83eda-59fc-464f-86ed-d881ffdb2977&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Reaching Client Goals with Power Wheelchairs

Reaching Client Goals with Power Wheelchairs

Reaching client goals with power wheelchairs: An evidence-based approach to power seat &
standing functions.

Thursday 17th September 2020 – 3:00 PM – 4:00 PM BST

Innova Care Concepts welcomes you to register for their free webinar – “Reaching client goals with power wheelchairs”. Power wheelchair provision is associated with many benefits such as increased mobility status, participation, and quality of life. The provision of power seat and standing functions can further optimise functional and clinical outcomes for power wheelchair users. Agenda & Learning Outcomes During this webinar you’ll learn more about:

  • Different power seat functions and the potential outcomes they can facilitate for clients.
  • Functional and clinical benefits of using standing function.
  • Real-world experiences of standing and power seat function users.

There will be a focus on the evidence supporting these outcomes. This webinar is supported by Permobil. Registration To register, please complete the contact form below. You will then receive a confirmation email containing all details to join the webinar. After the webinar, a handout and recording of the session will be sent to all registered attendees. So, if you can’t join us live (or want to rewatch), you can review everything at a later date. Speaker Bios Arne Compernolle has a background of electro-mechanics and occupational therapy, plus vast experience working in the field with wheelchairs users, offering solutions to increase their functional level. He became Clinical & Training Manager for Permobil EMEA in 2015. His ambition is to provide a better and evidence-based understanding to drive functional and clinical outcomes from wheelchair intervention, and to improve usability and user-friendliness of assistive technology. Ramsey Hulbert is a Specialist Equipment Advisor at Innova Care Concepts. He has over 15 years’ experience with specifying power wheelchairs and offers advice to wheelchair users, their caregivers, and clinicians every day. His main goal is to match a power wheelchair to a client’s individual goals and requirements – providing the right consultation, functions, and setup to maximise quality of life.

Click Here to Register or Find out More


Published: 2nd September 2020

Source: Innova Care Concepts

Page URL: https://register.gotowebinar.com/register/8590290143410030094?source=SoMe%20Facebook

Using the UKCA Mark from 1st January 2021

Using the UKCA Mark from 1st January 2021

Find out if you will need to use the new UKCA marking and how to use it.

Regulating Medical Devices from 1st January 2021

Regulating Medical Devices from 1st January 2021
How medical devices are regulated in the UK will change after the transition period has ended.

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.

This guidance provides information on how the UK system will operate, including for:

  • Getting your device certified
  • Conformity marking your device
  • Registering your device with the MHRA

This guidance is divided into sections on the different rules in Great Britain (England, Wales and Scotland), Northern Ireland and the EU.

For Northern Ireland, different rules will apply to those in Great Britain after the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see ‘Regulation of medical devices in Northern Ireland’

This guidance does not cover other ‘New Legislative Framework’ products which are subject to separate guidance.

The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval.

This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

Summary of key requirements for placing a device on the Great Britain market

From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:

  • CE marking will continue to be used and recognised until 30 June 2023
  • Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
  • A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021
  • From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
    • 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
    • 8 months for other Class IIb and all Class IIa devices
    • 12 months for Class I devices
  • If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Further detail on the UK Responsible Person is set out below.

The legislation

Legislation that will apply to Great Britain

Currently, devices are regulated under:

These directives are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). These Regulations (in the form in which they exist on 1 January 2021) will continue to have effect in Great Britain after the transition period.

The EU Medical Devices Regulation (MDR) and EU in vitro Diagnostic Medical Devices Regulation (IVDR) from 1 January 2021

The MDR and IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. As these regulations will not take effect until after the transition period with the EU has ended, they will not be EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain.

The Independent Medicines and Medical Devices Safety Review, which delivered its report this July, has highlighted the importance of strengthened regulations that do more to protect patients. We are committed to improving the standards and scrutiny of medical devices that reach UK patients. This will be enabled through the powers currently being created through the Medicines and Medical Devices Bill.

We have the opportunity to develop a robust, world-leading regulatory regime for medical devices that puts patient safety at the heart of the regulatory system. We will take into consideration international standards and global harmonisation in the development of our future system.

We will engage with stakeholders within the life sciences and healthcare sectors this autumn. As part of these discussions, we will identify elements that promote public health and patient safety, putting these at the heart of what we do. This will be followed by a formal public consultation with the aim of delivering an attractive world-class regulatory system.

There is further information below on how devices that have already been registered with the MHRA under the MDR or the IVDR will be regulated.

The role of the MHRA

The MHRA will continue to perform market surveillance of medical devices on the UK market and will be able to take decisions over the marketing and supply of a device in the UK.

The MHRA will continue to be responsible for the designation and monitoring of UK Conformity Assessment Bodies.

Further guidance is available on how the MHRA enforces the legislation on medical devices.

Requirements for those manufacturing and supplying devices in the UK

From 1 January 2021, the roles and responsibilities of those manufacturing and supplying medical devices and IVDs will change.

Manufacturers wishing to place a device on the UK market will first need to register with the MHRA. See guidance on registrations for more information.

Where a manufacturer is not established in the UK, in most cases it will need to designate a UK Responsible Person to register and act on its behalf. See guidance on UK Responsible Persons below for more information.

Manufacturers will need to comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs. See below for guidance on UKCA mark and Conformity Assessment Bodies and guidance on CE marking and Notified Bodies for more information.

Registrations in Great Britain

From 1 January 2021, any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.

The MHRA will only register devices where the manufacturer has a registered place of business in the UK. If the manufacturer is based outside the UK, they will need to designate a UK Responsible Person that has a registered place of business in the UK. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.

Manufacturers based outside the EEA who have an Authorised Representative that is established in Northern Ireland will not need to designate a UK Responsible Person when placing a device on the Northern Ireland market. In such cases, the Northern Ireland-based Authorised Representative will be able to register devices with the MHRA on the manufacturer’s behalf.

Once you are satisfied that your device meets all the relevant legal requirements set out above, you will be able to register it with the MHRA. Please note that these new registration requirements will not apply until 1 January 2021.

Registering your device from 1 January 2021

Given that this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process.

For the following devices, you will have 4 months to register with the MHRA (until 30 April 2021):

  • Active implantable medical devices
  • Class III medical devices
  • Class IIb implantable medical devices
  • IVD List A

For the following devices, you will have 8 months to register with the MHRA (until 31 August 2021):

  • Class IIb non-implantable medical devices
  • Class IIa medical devices
  • IVD List B
  • Self-test IVDs

For the following devices, you will have 12 months to register with the MHRA (until 31 December 2021):

  • Class I medical devices
  • General IVDs

Registration for custom-made devices will be in line with the risk class of the device. Failure to register by these dates will mean that you will no longer be able to lawfully place your device on the UK market.

More information on registrations (including fees) can be found in the MHRA’s registrations guidance.

UK Responsible Person

As noted above, to place a device on the Great Britain market, manufacturers based outside the UK will need to designate a UK Responsible Person that is established in the UK.

From 1 January 2021, the UK Responsible Person will act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the manufacturer’s devices can be placed on the UK market.

The responsibilities of the UK Responsible Person will be set out in the UK MDR 2002 (in the form in which they exist on 1 January 2021). In summary, the UK Responsible Person must:

  • Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
  • Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
  • In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
  • Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
  • Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.

UKCA mark and Conformity Assessment Bodies

UKCA mark

The UKCA (UK Conformity Assessed) mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market after the transition period. The UKCA mark will not be recognised in the EU, EEA or Northern Ireland markets, and products currently requiring a CE marking will still need a CE mark for sale in these markets. Manufacturers will be able to use the UKCA mark from 1 January 2021.

From 1 July 2023, to place a device on the Great Britain market, you will need to meet the requirements for placing a UKCA mark on your device.

UK Conformity Assessment Bodies

From 1 January 2021, the MHRA will be able to designate UK Conformity Assessment Bodies (CABs) to conduct assessments against UK requirements for the purpose of the UKCA mark.

UK Notified Bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process. These Notified Bodies will be known as ‘Approved Bodies’ as of 1 January 2021.

UK Approved Bodies will only be able to conduct conformity assessments as follows:

  • For medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (in the form in which they exist on 1 January 2021)
  • For medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (in the form in which they exist in Northern Ireland)
Class I device manufacturers

Manufacturers of Class I medical devices and general IVDs will be able to self-declare their conformity against Part II and Part IV of the UK MDR 2002 (in the form in which they exist on 1 January 2021), before affixing a UKCA mark and placing the device on the Great Britain market. Class I medical devices that are sterile or have a measuring function will still require approval from an Approved Body in order to be affixed with the UKCA mark and placed on the Great Britain market.

CE marking and Notified Bodies

CE marking

The MHRA will continue to recognise the CE mark for devices until 30 June 2023. This will apply to devices placed on the Great Britain market that have been CE marked under and fully conform with the following applicable EU legislation:

From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements.

If you currently CE mark your medical device on the basis of self-certification, you will be able to continue to do so after 1 January 2021 and place your device on the Great Britain market until 30 June 2023.

Devices that have been CE marked by Northern Ireland traders will continue to be accepted on the Great Britain market beyond 30 June 2023. This will apply to devices that have been self-certified or have undergone mandatory third-party conformity assessment by an EEA-based Notified Body. Please see further guidance below on regulation of medical devices in Northern Ireland.

Notified Bodies

Certificates issued by EEA-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023.

If you wish to place a CE marked device on the Great Britain market from 1 January 2021, any mandatory third-party conformity assessment and certification will need to have been conducted by an EEA-based Notified Body. This will allow you to place a CE mark on your device and place it on both the UK and EU markets.

Recognition of existing CE certificates for the Great Britain market

From 1 January 2021, under the UK MDR 2002 (in the form in which they exist on 1 January 2021), a CE marked device with a valid declaration of conformity or certificate will be viewed as meeting the UKCA mark requirements whilst the CE mark continues to be recognised in Great Britain. This will include devices placed on the market that conform with the EU MDR or EU IVDR.

Therefore, any enforcement or market surveillance powers available in respect of the UKCA mark will apply to CE marked devices. Where your certificate has been issued by a UK Notified Body, the Body will be re-designated as a UK Approved Body and will continue to oversee these devices and their manufacturers to ensure continued compliance with the applicable standards of safety and performance under the UKCA mark.

Labelling requirements

As of 1 January 2021, medical devices placed on the Great Britain market will need to have either a UKCA mark or a CE mark, depending on which legislation the device has been certified under.

Where relevant, the number of the Notified Body or Approved Body will also need to appear on the label.

If you already have a valid CE mark on your device, you will not be required to re-label the device with a UKCA mark until 1 July 2023 for placement on the Great Britain market.

Post-market surveillance and vigilance

Once a medical device has been placed on the UK market, the manufacturer will continue to be required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device. They must also continue to take appropriate safety action when required. The manufacturer will need to ensure their device meets appropriate standards of safety and performance for as long as it is in use.

Further information about reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices.

Regulation of medical devices in Northern Ireland

Under the terms of the Northern Ireland Protocol, from 1 January 2021, the rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain.

There will be a requirement to register devices with the MHRA and have a UK Responsible Person if the manufacturer is based outside the UK, as set out below.

EU MDR and EU IVDR

The Medical Device Regulations (2017/745) and the in vitro Diagnostic Medical Device Regulations (2017/746) will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline.

CE marking for the Northern Ireland market and implications for UK Approved Bodies

Although the UKCA mark will need to be used in Great Britain from 1 July 2023, a CE mark will continue to be needed for devices placed on the Northern Ireland market and EU rules will need to be met.

If you currently CE mark your device on the basis of self-certification, you will be able to continue to do so for the purposes of the Northern Ireland market. You will need to use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment in order to CE mark your device. This will allow it to circulate in the EU.

UK Approved Bodies will be able to conduct conformity assessments for the purposes of the Northern Ireland market. Where a device has been assessed by a UK Approved Body, the UK(NI) mark will accompany, but not replace, the CE mark. Products carrying both the CE mark and UK(NI) mark cannot be placed on the EU market.

UKCA marked devices will not be accepted on the Northern Ireland market unless accompanied by the CE or CE UK(NI) mark.

Registration and UK Responsible Person requirements for Northern Ireland

Manufacturers wishing to place a device on the Northern Ireland market must first register with the MHRA. Please see the MHRA’s guidance on registrations for more information.

Where a manufacturer is established in Great Britain, it will need to designate a Northern Ireland or EU Authorised Representative in order to place a device on the Northern Ireland market. Where the designated Authorised Representative is based in Northern Ireland, it will be required to register with the MHRA, devices of all classes placed on the Northern Ireland market (including custom-made devices and IVDs). Where the designated Authorised Representative is based in the EU, there is no requirement to register Class I and custom-made devices or general IVDs. All other devices placed on the Northern Ireland market must be registered with MHRA.

Where a manufacturer is not established in Northern Ireland or elsewhere in the UK, it will need to designate a UK Responsible Person to register and act on its behalf.

This requirement will not apply to manufacturers based outside the EEA who have an Authorised Representative based in Northern Ireland. In such cases, the Northern Ireland-based Authorised Representative will be able to register the device on behalf of the outside-EEA manufacturer.

Post-market surveillance and vigilance

The MHRA will continue to be the Competent Authority for post-market surveillance activity for devices placed on the Northern Ireland market. Where incidents occur in Northern Ireland, these will need to be reported to the MHRA.

Placing a medical device on the EU market

CE marking for the EU market after the transition period

From 1 January 2021, devices destined for the EU market will need to adhere to the relevant EU legislation and be affixed with the CE mark to demonstrate compliance.

The UKCA mark will not be recognised on the EU market unless it accompanies the CE mark.

If you use a UK-based Notified Body (‘Approved body’) to conduct any mandatory third-party conformity assessment for your device, the following will apply:

  • if your device is placed on the EU market before 1 January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market.
  • from 1 January 2021, you will not be able to place a device on the EU market if your mandatory third-party conformity assessment has been conducted by a UK Notified Body.
Conformity assessment

The results of mandatory conformity assessment carried out by UK Notified Bodies (Approved Bodies) will not be recognised by the EU. This is the case even if the assessment is carried out before the end of the transition period, unless the product has already been placed on the EU market before 1 January 2021.

If you wish to place a medical device on the EU market after 31 December 2020 that must undergo mandatory third-party conformity assessment, you will need to use an EEA-based Notified Body.

If you currently CE mark your medical device on the basis of self-certification, you will be able to continue to do so after 1 January 2021 for the purposes of the EU market, but will need to appoint an EU or Northern Ireland-based Authorised Representative.

Your UK Notified Body may already be taking steps of its own, so that you can continue to export to the EU without needing to find a new EU Notified Body yourself.

If not, you will need to either:

  • Get your devices reassessed by an EU-recognised Notified Body
  • Arrange for the files to be transferred to an EU-recognised Notified Body before 1 January 2021
Authorised Representatives

Great Britain-based Authorised Representatives will not be recognised in the EU from 1 January 2021, regardless of when products were placed on the market. This means that they will not be recognised as able to carry out tasks on the manufacturer’s behalf for the purposes of placing devices on the EU market.

If you are a manufacturer based outside the EU and you currently have a Great Britain-based Authorised Representative, you should make plans to engage an Authorised Representative based in the EU or Northern Ireland.

If you are a Great Britain-based manufacturer and wish to continue to supply CE marked devices to the EU market, you will need to establish an Authorised Representative based in the EU or Northern Ireland, to register and act on your behalf.

Labelling requirements

From 1 January 2021, you will need to ensure that your device meets EU labelling requirements in order to place it on the EU market.


Published: 1st September 2020

Source: GOV UK, Medicines and Healthcare products Regulatory Agency

Page URL: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021

THIIS Issue 264 – September 2020

THIIS Issue 264 – September 2020

Placing Manufactured Goods on the Market in Great Britain from 1st January 2021

Placing Manufactured Goods on the Market in Great Britain from 1st January 2021

What you need to do to comply with regulations on manufactured goods you place on the GB market from 1 January 2021.

This guidance is about placing manufactured goods on the market in Great Britain (GB). Great Britain is England, Wales and Scotland.

There’s different guidance if you’re:

If you have already placed your good on the UK market (or in an EU country) before 1 January 2021, you do not need to do anything.

Businesses are encouraged to be ready for full implementation of the new UK regime as soon as possible after 1 January 2021. However, to allow businesses time to adjust, CE marked goods in scope of this guidance that meet EU requirements (where these match UK requirements) can continue to be placed on the GB market until 1 January 2022 where EU and UK requirements remain the same. This includes goods which have been assessed by an EU recognised notified body. There are some exceptions to this guidance, highlighted below.

Check which rules apply

What you will need to do from 1 January 2021 depends on the type of goods you’re placing on the market.

Most of this page covers goods often known as new approach goods.

There are different rules for:

  • goods regulated under the old approach
  • goods covered by national rules (non-harmonised)
  • certain other goods, such as medical devices and civil explosives

Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

Old approach goods

You must follow different rules if you’re placing the following goods on the UK market:

Goods covered by national rules (non-harmonised)

You must make sure that your goods meet UK rules. You’ll need to do this even if they were previously sold in an EU country.

Check the UK product safety rules to find out what you need to do.

Other goods

There are also special rules if you’re placing the following goods on the UK market:

Check if you need to change your conformity assessment or marking

You need to use a conformity mark if you’re placing certain goods on the UK market. Before 1 January 2021 you can do this using the CE mark or other appropriate mark (such as the wheel marking or Pi mark).

From 1 January 2021, the UKCA mark will be the conformity assessment marking for Great Britain for most goods currently subject to CE marking.

The CE marking will be accepted in the UK until 1 January 2022 for certain products. You must be ready to use the UKCA marking from 1 January 2022 at the latest, although you should look to use the UKCA marking as soon as possible.

Using the UKCA marking

You will need to use the new UKCA marking immediately after 1 January 2021 if all of the following apply. Your product:

This does not apply to existing stock, for example if your good was fully manufactured and ready to place on the market before 1 January 2021.

Contact your solicitor or trade association for advice on whether your good will be affected.

Find out how to use the UKCA marking.

Using the CE marking

CE marking for the GB market

You will be able to use the CE marking until 31 December 2021 if any of the following apply:

  • you currently apply the CE marking to your good on the basis of self-declaration
  • any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (including a body in a country with which the EU has a relevant mutual recognition agreement)
  • the certificate of conformity previously held by a UK approved body has been transferred to an EU-recognised notified body

You can only place CE marked goods that meet EU requirements in Great Britain while UK and EU requirements are the same. This will be the case on 1 January 2021 and there are no UK plans to diverge at this time. Nonetheless you are encouraged to be ready as soon as possible, and by 1 January 2022 at the latest. If the EU changes their rules and you CE mark your goods based on new EU rules which are different from the requirements in the UK, you will no longer be able to use the CE marking in the UK. This will be the case even if the change happens before 1 January 2022.

Find out how to use the CE marking.

CE marking for both the GB and EU market

The UKCA marking will not be recognised on the EU or Northern Ireland markets. Products currently requiring a CE marking for sale in the EU will continue to need a CE mark.

You will not need to take any action from 1 January 2021 if either of the following apply:

  • you self-declare the conformity of your good against the regulations
  • you voluntarily use a testing or notified body to test against European or international standards

You may need to take additional action if your good needs third-party conformity assessment.

Check whether your UK notified body is taking steps that help you continue to export to the EU without needing to find a new EU notified body.

If not, you may need apply for a new certificate from an EU notified body. Your existing notified body should provide another body of your choice information relating to your conformity assessments in order to facilitate this.

Speak to your testing body or solicitor for advice on how conformity processes for your good will be affected.

Find out how to use the CE marking.

Using both the CE and UKCA marking

Goods can carry both the CE and UKCA markings so long as they are fully compliant with both UK and EU regulations.

From 1 January 2021 the essential requirements and standards that can be used to demonstrate conformity with them for UKCA marked goods will be the same as they are now. That means that if your goods is currently made to the technical requirements necessary for CE marking then it will be made to the same technical requirements that will exist for UKCA marking from 1 January 2021. However, the conformity assessment bodies that test them may need to be different.

Appoint an authorised or responsible person in the UK

Authorised representatives and responsible persons based in the EU will no longer be recognised in Great Britain from 1 January 2021.

If you need to (or choose to) use an authorised representative or responsible person, they will need to be based in the UK for products being placed on the GB market.

Manufacturers

Your legal obligations will remain largely unchanged from 1 January 2021.

UK distributors and suppliers

You’ll need to confirm whether you or your supplier will become an ‘importer’ after 1 January 2021.

You’ll become an importer if you’re the one bringing goods into the UK from outside the UK and placing them on the market in Great Britain.

You’ll need to make sure:

  • goods are labelled with your company’s details, including your company’s name and a contact address (until 31 December 2022 you can provide these details on the accompanying documentation rather than on the good itself)
  • the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings
  • the manufacturer has drawn up the correct technical documentation and complied with their labelling requirements
  • you maintain a copy of the declaration of conformity for a period of 10 years
  • goods conform with the relevant essential requirements

More information

Existing stock

Existing stock that has been fully manufactured and conformity marked can still be placed on the GB market after 1 January 2021 with existing markings and notified body numbers. This is true even if this would otherwise not be the case.

For example, a product covered by a UK certificate of conformity, and which would normally need UKCA marking after 1 January 2021, can still be sold in the UK with a CE marking so long as it is from pre-existing stock fully manufactured before 31 December 2020.

Relevant UK and EU legislation

The table below lists the current EU legislation for specific goods, and the title of the corresponding UK legislation.


Published: 1st September 2020

Source: GOV UK, Department for Business, Energy & Industrial Strategy

Office for Life Sciences Bulletin – 1st September 2020

Office for Life Sciences Bulletin – 1st September 2020

The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS).
This is a special bulletin to inform the life sciences sector that the MHRA has published detailed guidance on how medicines and medical devices will be regulated at the end of the Transition Period, in both a negotiated and non-negotiated outcome with the EU. This is to provide you with information from Government to help your members and networks prepare.


Published: 1st September 2020

Source: Office for Life SciencesGOV UK

Webinars: Preparing to make Submissions to the MHRA from 1st January 2021

Webinars: Preparing to make Submissions to the MHRA from 1st January 2021

Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems to use from 1 January 2021.

Placing Manufactured Goods on the EU Market from 1st January 2021

Placing Manufactured Goods on the EU Market from 1st January 2021

What you need to do to comply with regulations on manufactured goods you place on the market from 1 January 2021.


This guidance is about placing manufactured goods on the EU market.

There’s different guidance if you’re:

If you’ve already placed your goods on the market in an EU country (or in the UK) before 1 January 2021, you do not need to do anything.

Check which rules apply

What you will need to do from 1 January 2021 depends on the type of goods you’re placing on the market.

Most of this page covers goods known in the EU as new approach goods, which can use the CE marking.

There are different rules for:

  • goods regulated under the old approach (such as chemicals, medicines and vehicles)
  • non-harmonised goods covered by national legislation

Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

Old approach goods

You must follow special rules if you’re placing these goods on the EU market.

Check the European Commission’s website for the latest information.

Non-harmonised goods

You must make sure that your goods meet the requirements of the first EU or EEA country in which you are placing them on the market.

Check the national regulations of the relevant EU/EEA country to find out what you need to do.

Check if you need to change your conformity assessment

You will not need to change your conformity assessment for exports to the EU if:

  • you self-declare the conformity of your good against the regulations
  • any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (whether based in the EU or in a country with which the EU has a mutual recognition agreement)
  • the certificate of conformity previously held by a UK body has been transferred to an EU-recognised notified body
  • you voluntarily use a testing body (including UK bodies) to test against European or international standards

Find out how to use the CE marking.

UK conformity assessment

From 1 January 2021 any mandatory conformity assessment will need to be carried out by an EU-recognised conformity assessment body. This includes both EU based bodies and bodies in countries with which the EU has concluded a mutual recognition agreement.

UK conformity assessment bodies will no longer be able to carry out mandatory conformity assessment for products being placed on the EU market unless agreed in negotiations.

Speak to your testing body or solicitor for advice on how conformity processes for your good will be affected from 1 January 2021.

Appoint an EU-recognised notified body

Check whether your UK notified body is taking steps of its own, so that you can continue to export to the EU without needing to find a new EU notified body yourself.

If not, you will need to either:

  • get your products reassessed by an EU notified body
  • arrange for information held by your existing notified body to be transferred to an EU notified body so they can issue you a new certificate
Certificates and documentation

If you transfer your existing certificate to an EU notified body then you will need to update the 4-digit notified body number on your products. You will not need to do this for products already on the market or which were manufactured before the transfer took place.

You will eventually need separate certificates for the UK and EU. You should speak to both your existing and new body to make arrangements that mean you will be covered for both markets in the future. If you transfer your certificate to the EU without doing this you may not be able to continue selling your goods in the UK from 1 January 2022 without having your product reassessed. This process may take a long time so you should start now.

EU and UK notified bodies are required to share information when requested by a certificate holder. This will help facilitate the issuing of new certificates of conformity where needed.

Appoint an authorised or responsible person

Authorised representatives and responsible persons based in Great Britain will no longer be recognised by the EU from 1 January 2021.

If you’re required to, you will need to appoint an authorised representative or responsible person based in the EU, EEA or Northern Ireland.

From 16 July 2021 you will need to appoint an authorised representative based in the EU or EEA if you sell goods without using an importer or fulfilment service provider. For example if you sell online and ship directly to the end user.

Manufacturers

Your legal obligations will remain largely unchanged from 1 January 2021.

EU-based distributors

If you have an EU based distributor they will become an ‘importer’ from 1 January 2021.

They will need to make sure:

  • goods are labelled with their address and either your details or your EU, EEA or Norther Ireland-based authorised representative’s details (including your company’s name and a contact address or registered trademark)
  • the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings
  • you, as the manufacturer, have drawn up the correct technical documentation and complied with the labelling requirements
  • they maintain a copy of the declaration of conformity for a period of 10 years
  • goods conform with the relevant essential requirements
EU-based fulfilment service providers

From 16 July 2021, if you use an EU-based fulfilment service provider, they will need to request certain compliance information from you, and goods will need to be labelled with their details.

They may ask that you appoint an authorised representative who can fulfil these obligations instead.

More information

This guidance is based on information published by the European Commission. For the latest updates on the EU’s requirements please consult the European Commission’s website.


Publised: 1st September 2020

Source: GOV UK, Department for Business, Energy & Industrial Strategy

Page URL: https://www.gov.uk/guidance/placing-manufactured-goods-on-the-eu-market-from-1-january-2021?utm_source=e3ecaa9a-e445-40ca-bf8e-624cbd7c4042&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

THIIS Connect to bring the Mobility, Access and Independent Living Trade Together

THIIS Connect to bring the Mobility, Access and Independent Living Trade Together

A New digital platform designed to connect mobility buyers and sellers together,
THIIS is inviting retailers to register their interest to participate in phase 2


THIIS Magazine has launched a new platform designed to make it easy for retailers, distributors and installers to discover suppliers and the latest products in the market.

With important trade shows cancelled this year, alongside less sales representatives on the road, it can be difficult for retailers and installers in the sector to connect with suppliers to find out about the latest solutions available to end-users.

Now, as the industry finds its feet after lockdown, ensuring mobility and access buyers & sellers can continue to do business is more important than ever.

To that end, THIIS Magazine has launched THIIS Connect.

The new digital platform brings key suppliers and products in the market together in one central hub for THIIS’ 35,000+ monthly website visitors to easily discover.

THIIS Connect enables trade buyers to connect with suppliers through its supplier and product search functionality.

The supplier search function provides buyers with all the information they need to know about a manufacturer or distributor, including a company description, contact details, introductory videos and a showcase of their products.

The product search function allows buyers searching for a specific product to quickly identify which ranges are on the market, along with information about the product and supplier.

Currently in its first phase of development, the next stage of THIIS Connect will extend the search functionality to include retailers and installers. This will enable suppliers in the market to find retailers from all across the country where they may be looking for exclusive trade partners or wishing to offer unique offers.

Retailers and installers interested in having their companies featured on THIIS Connect can register their interest here: https://thiis.us11.list-manage.com/subscribe?u=a2932f3d53c05818a2911f554&id=e5e78ef18f

Suppliers keen to have their details and products included on THIIS Connect should contact Joe Fahy on 07384 258 372 or email joe.fahy@bhtaengage.com

Visit THIIS Connect to connect with suppliers and search new products here: https://thiis.co.uk/thiis-connect-trade-directory/


Published: 28th August 2020

Source: THIIS Magazine

UK AT Sector Welcomes the Essential Assistive Products List Survey

UK AT Sector Welcomes the Essential Assistive Products List Survey

The British Assistive Technology Association and World Health Organisation GATE Programme are pleased to have received an overwhelmingly positive response to the UK APL (Assistive Products List) survey.

Initial organisational stakeholders aware of the initiative, met on 21st July and have subsequently committed to supporting the UK APL roadmap. The goal is to bring together all those using or connected to AT, to develop a list of which assistive products are essential for living a fully accessible life in the UK today.

Through establishing this first UK APL, we see that as a newly unified stakeholder community we shall be able to move forward to provide policy makers with the opinions and data they need to advance equitable access to high-quality AT in the UK.

As a group of stakeholders we will be a space for the voices of the UK AT ecosystem to hear each other’s concerns, and firstly work together to identify what barriers and gaps there are to accessing the most essential assistive products that people need in the UK in 2020-21.

To establish a comprehensive UK APL we are reaching out to all organisations and individuals who use assistive products, to complete the survey and make recommendations of which products that they feel should be considered for the final essential list.

The survey is based upon the WHO global template APL and is a guide for us to develop. We must devise an APL to represent our own experience in the UK today, so please take the time to complete the survey which can be found here: https://bit.ly/UKAPL and strengthen the message of how vital AT is in our lives.

Please connect to the group or groups of stakeholders that are important to your area of experience and knowledge. Links to where you can apply to join the specialised domain stakeholder groups are also found on this page.

Esther Dakin-Poole, the UK APL Coordinator would welcome all organisations, individual users and advocates to contact her. You can inform her about your work or lived experience and formally confirm your involvement. This will ensure that you or your organisation are fully represented and that you are kept informed of progress.

Remember, if you wear a pair of reading glasses or orthotics in your shoes, you use AT. AT is everywhere and luckily it is widely available in the UK for the many not just the few. Make your voice heard and take the survey today: https://bit.ly/UKAPL

To contact Esther Dakin-Poole, UK APL Coordinator please email: ukapl@bataonline.org


Published: 14th August 2020

Source: BATA (British Assistive Technology Association)

Page URL: https://www.bataonline.org.uk/articles/uk-sector-welcomes-essential-assistive-products-list-survey

Office for Life Sciences Bulletin – 21st August 2020

Office for Life Sciences Bulletin – 21st August 2020

The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS).
This bulletin aims to keep the life sciences sector up to date on the latest guidance whilst the UK is in the transition period and during the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks prepare.


Published: 21st August 2020

Source: Office for Life SciencesGOV UK

More than Half a Billion Pounds to Help People Return Home from Hospital

More than Half a Billion Pounds to Help People Return Home from Hospital
An older woman sitting in an armchair using a laptop
https://www.gov.uk/

People needing additional follow-on care after being discharged from hospital will be supported by a £588 million fund to cover adult social care or the immediate costs of care in their own home.

  • £588 million will provide up to 6 weeks of funded care and support for people being discharged from hospital
  • Funding could pay for additional support including domiciliary care, community nursing services or care home costs
  • Assessments for those needing funded long-term care or support to resume from September

People needing additional follow-on care after being discharged from hospital – including older people and those with disabilities – will be supported by a £588 million fund to cover adult social care or the immediate costs of care in their own home.

From 1 September, the NHS will be able to access the funding in order to provide up to 6 weeks of additional support so people can receive ongoing help with their recovery and rehabilitation after they leave hospital. This could include support in their home or access to services such as physiotherapy.

NHS Continuing Healthcare (NHS CHC) assessments will also restart from September ensuring those with complex health needs can continue to access the care they need for free.

Health and Social Care Secretary, Matt Hancock, said:

We know for the majority of people the road to recovery can be quicker when they receive care and support in the comfort of their own home.

This funding will help ensure people can be safely discharged from hospital knowing they will get the vital follow-on care they need to recover fully from treatment.

We’re also making sure those with complex health needs continue to receive the best support possible in the community.

Most people will be discharged back to their homes. However, it is anticipated that a very small proportion will need, and benefit from, short or long-term residential, nursing home or hospice care.

It remains the case that no one should be discharged from hospital directly to a care home without the involvement of the local authority, and that all patients are required to be tested prior to discharge to a care home. No care home should be forced to admit an existing or new resident who has tested positive for coronavirus if the home would be unable to cope with the impact of their illness.

Councillor​​​​​​ Paulette Hamilton, Vice Chair of the Local Government Association’s Community Wellbeing Board, said:

We are pleased to see this further injection of funding to ensure that people can leave hospital as soon as is safe and return home wherever possible. We are also reassured by the commitment that no one will go into a care home without having been tested for the virus. Local government has asked for these commitments and will continue to play a key role in making them happen.

New guidance has been published to help hospitals safely discharge patients into the appropriate setting to maximise their independence and ensure they can remain in their own homes as much as possible.

A comprehensive care and health assessment for any ongoing care needs, including determining funding eligibility, will take place within the first 6 weeks following discharge to make sure individuals have the support they need.

The funding can also be used for urgent community response support to prevent someone being admitted to hospital. This can include providing urgent domiciliary care or nursing support, like basic wound care, in someone’s own home, rather than in hospital.

Case managers will ensure people are discharged safely, on time and that they have full information and advice about what is happening. This includes how individuals’ needs will be assessed and any follow up support that may be required. This approach applies to anyone discharged from NHS community and acute beds.

The funding is part of the £3 billion provided to protect and prepare health and social care in the event of a second peak of COVID-19 during winter and follows £1.3 billion funding made available via the NHS to support the discharge process in March.

The government has expanded the ONS infection survey to provide extensive, weekly data on the spread of infection, supporting rapid testing and diagnosis of COVID-19 both nationally and in areas of concern.

Background information

The new guidance, Hospital discharge service: policy and operating model, sets out the operating model for all NHS trusts, community interest companies, and private care providers of acute, community beds and community health services and social care staff in England. It replaces the hospital discharge service requirements issued on 19 March 2020 to support the response to the COVID-19 pandemic.

These new funding arrangements will apply up until 31 March 2021.

NHS CHC teams will work closely with community health and social care staff in supporting people on discharge pathways 1, 2 and 3, to ensure appropriate discussions and planning concerning a person’s long-term care options happen as early as possible during the 6-week discharge pathway. This close working and communication will also ensure time is allowed for the CCG to undertake the full NHS CHC assessment and for local authority staff to undertake Care Act assessments where it is needed.

Further advice for measures to be taken if patients are discharged into the community is provided in home care guidance and supported living guidance. These guidance documents state that:

  • all people admitted to hospital to receive care will be tested for COVID-19, and hospitals should share care needs and COVID-19 status with relevant community partners planning the subsequent community care.
  • as set out in the COVID-19 adult social care action plan, any individual being taken on by a home care or supported living care provider should be cared for as possibly COVID-positive until a 14-day period has passed, within their home.
  • if a care home provider does not feel they can provide the appropriate isolation for those coming out of hospital, the individual’s local authority should secure alternative appropriate accommodation and care for the required isolation period. Costs of providing alternative accommodation are covered by discharge funding provided via the NHS


Published: 21st August 2020

Source: GOV UK, Department of Health and Social Care

Page URL: https://www.gov.uk/government/news/more-than-half-a-billion-pounds-to-help-people-return-home-from-hospital

Guidance on Safe Working During the COVID-19 Pandemic

Guidance on Safe Working During the COVID-19 Pandemic

Executive Summary – Guidance on safe working during the COVID-19 pandemic

The current COVID-19 pandemic has fundamentally shifted the way people live and work.

As the pandemic impacted different regions, many countries faced a sudden ‘lockdown’. With populations confined to their own homes, organizations of all types had to change the way they operated or shut down entirely, with little or no time to prepare. Following the initial global crisis, a cycle is emerging: outbreaks are controlled and restrictions are eased, new clusters of cases emerge and restrictions need to be reintroduced.

This means a rethink of what was previously considered normal, and ensuring plans are in place to respond rapidly if restrictions are introduced, changed or eased at short notice.

Capturing the lessons learned as we progress through the phases of the pandemic is crucial. Whilst economic considerations are important, the fundamental principle of protecting human life underpins all economic recovery.

All organizations face questions from their customers, suppliers, investors and the general public. The most important stakeholders for the success of an organization, however, are the workers. Planning how to mitigate the effects of the pandemic is therefore crucial in order to protect workers, provide reassurance to other interested parties and to protect the organization’s reputation.

Building on, and complementing, formal guidance issued by governments and other trusted sources such as the World Health Organization (WHO), BSI has developed this set of guidelines to assist organizations as they adjust the way they work, and to protect workers, and the people they come into contact through work, from the ongoing risks.

The Guidelines are a response to the COVID-19 pandemic and the increased risk this disease presents to the health, safety and well-being of people in all settings, including whilst working and in the workplace.

Governments, regulators and other professional bodies across the world have published guidance on working safely during the COVID-19 pandemic. This document aims to provide a single generic set of guidelines that complement this information and support the principle that workers should not be required to work unless all reasonable measures have been taken to manage work-related COVID-19 risks.

The Guidelines includes practical recommendations to organizations and workers on how to manage these risks and is suitable for organizations resuming operations, those that have been operational throughout the pandemic, and those that are starting operations.

These Guidelines have been produced by BSI with input from experts from a broad range of sectors. They provide a general framework for safe working during the pandemic, to protect people from work-related risks from COVID-19.

Benefits of using these guidelines

  • Provides a single source of agreed good practice and accurate advice, based on current knowledge.
  • Supports comprehensive risk assessment.
  • Provides practical examples for ways of managing risks.
  • Enables organizations to plan in a similar way across multiple sites and for multiple types of workers performing different activities and roles.
  • Helps organizations to manage the risk of communicable diseases and can reduce sickness absence due to seasonal and other illness (e.g. common colds, influenza, gastric illness).
  • Assists organizations in developing a response plan to enable rapid adjustments if risk levels or operating restrictions change at short notice.

Key points applicable to all organizations

  1. Enhancing hygiene and enabling physical distancing are the most effective controls against communicable disease.
  2. Minimizing the number of people in a physical workplace, and physical interaction between people, reduces the risks to workers, customers and the community.
  3. Involving workers in decisions about managing risks leads to better engagement and performance.
  4. Facilitating and supporting remote working enables organizations to better manage the risks to people who need to be on-site.
  5. Managing the psychological health and well-being of workers is as important as protecting physical health and safety.
  6. Managing the health and safety of people working remotely is critical to mitigate the impacts of ergonomic, psychosocial and other risks.
  7. Providing effective and regular communication to workers and other relevant people is critical for success.
  8. Ensuring ongoing planning, monitoring and adaptation of safety measures enables organizations to avoid the risk of transmission rising due to complacency or familiarity.
  9. Maintaining and retaining accurate records of people who work closely together and customers in relevant sectors (e.g. restaurants, pubs) enables effective contact tracing.
  10. Providing effective leadership and developing a transparent, supportive and open culture helps organizations to manage the risks related to COVID-19 and enhances an organization’s ability to continue operations without severe disruption.


Published: 21st August 2020

Source: BSI

Page URL: https://www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/covid-19-guidelines/executive-summary/?utm_source=pardot&utm_medium=email&utm_campaign=SM-STAN-PRM-COVID19%2FGuidelines-2005

Renewed KIDS SAVE LIVES Campaign to Increase Awareness & Fight Sudden Cardiac Death during COVID-19

Renewed KIDS SAVE LIVES Campaign to Increase Awareness & Fight Sudden Cardiac Death during COVID-19

Renewed KIDS SAVE LIVES Campaign to Further Increase Awareness and Fight Sudden Cardiac Death in the era of COVID-19.

The European Resuscitation Council has recently published a position statement on schoolteachers’ education and qualification in cardiopulmonary resuscitation (CPR) and COVID-19 resuscitation guidelines, including adapted recommendations for education, courses, and basic and advanced life support. Educating schoolteachers in CPR and qualifying them to teach it to children as recommended by the worldwide ‘KIDS SAVE LIVES’ (KSL) initiative may help considerably and sustainably to improve survival worldwide after sudden out-of-hospital cardiac arrest (OHCA). The COVID-19 pandemic emerged in China at the end of 2019 and challenged most healthcare systems and societies worldwide. Many countries reacted with various lockdown measures to limit the spread of infection and to reduce death rates. Fortunately, children have not been severely affected compared with older people, but concern was expressed about their potential role in spreading infection, which resulted in a limitation of school activities. Thus, we have to consider that the impact of social distancing on teaching and the fear of interacting with a victim potentially infected with COVID-19 could severely reduce the willingness of children and teachers to teach and to provide CPR. While local school organisation can vary widely in term of spaces, timetables, web-based lessons and face-to-face activities, we acknowledge the urgent need for a refurbished KSL campaign, specifically addressing obstacles to bystander CPR provision during a pandemic. Awareness of the importance of providing effective CPR in OHCA during the pandemic requires special activities and support to overcome these barriers. Focus should be brought on the role of the community in helping save lives, the risk-benefit balance for young rescuers with the chance of saving a life, the importance of personal protection against infection and of local measures for disease surveillance, e.g. through dedicated apps, contact tracing, testing, etc. As a specific campaign, the authors propose a renovated KSL logo for use during the COVID-19 pandemic and, in agreement with the European Resuscitation Council, calls the international community for specific initiatives to reinforce and adapt the KSL campaign to the current context. Far too many people are still dying following OHCA worldwide, and hundreds of thousands of deaths could be avoided. All the communities must overcome the fear of COVID-19 to help KIDS to learn to save lives.


Published: 21st June 2020

Source: Resuscitation Journal, European Resuscitation Council

Page URL: https://www.resuscitationjournal.com/article/S0300-9572(20)30254-9/fulltext?utm_source=resuscounciluk_medium=li_date=120820

OT Show 2021

OT Show 2021

OT Show has been postponed to the 24th – 25th November 2021.

COVID-19 has brought enormous pressures and uncertainty to our personal and professional lives.

As we begin to adapt to this new normal, The OT Show team and I have felt privileged to be a part of an amazing care ecosystem which has led to all Occupational Therapists become national heroes for their determination and are seen as a vital sector in our Health and Care Systems. We have been humbled by the dedication, bravery and humanity demonstrated by the sector.

Postponed 

Although the government has made a decision to reignite mass gathering events from the 1st October, we the OT Show team feel the most ethical and moral decision based on the feedback from our exhibitors, delegates and our speakers that the Occupational Therapy Show will be postponed to the 24th & 25th November 2021.

The last few months have had a huge impact on both the mental and physical wellbeing of our community and we are dedicated to protecting the safety of our delegates, sponsors, and speakers as our top priority.

With the possibility of a second Covid-19 wave, the feedback we have received from all our partners is, as the largest and most established gathering of OT professionals in the UK; we should not run the show this year. OTs work with the most vulnerable in our society and we have a responsibility to protect them and their clients, and we feel strongly that the risk of attending any event this year is far too high.

 What happens next

Your booking has been automatically transferred to the 2021 dates and you will receive more marketing exposure to your potential customers during the build-up to the event next year. We will be increasing the amount of digital and printed promotion across the forthcoming months, meaning when OTs are ready to look at new products, services and suppliers, your brand will be at the forefront of their minds.

We are excited about the future and look forward to continuing to work with you to build an exciting OT Show in 2021.


Published: 20th August 2020

Source: The OT Show

Continuity of Medical Supplies at the End of the Transition Period

Continuity of Medical Supplies at the End of the Transition Period

Continuity of Medical Supplies at the End of the Transition Period

An introduction to the plans and preparations of the Department of Health and Social Care (DHSC) to support the continuity of medical supplies at the end of the transition period (end of December 2020).
This webinar follows from the recent letter from Steve Oldfield, Chief Commercial Officer, at the Department.

Click Here to Register

Meeting Climate Change Requirements from 1st January 2021

Meeting Climate Change Requirements from 1st January 2021

How climate change regulations, emissions trading, ecodesign and energy labelling will change from the 1st January 2021.

The UK has left the EU, and the transition period after Brexit comes to an end this year.

Click Here to check GOV UK for updates to this information.

Check what else you need to do during the transition period.

Meeting climate change requirements from 1 January 2021

Find out how this would affect:

  • climate change regulations
  • emissions trading
  • energy using products
  • ecodesign and energy labelling

19 August 2020

On 7 July 2020, the European Commission published a notice to stakeholders advising on technical issues in relation to the end of the transition period. We have updated this guidance note to reflect key developments.

22 April 2020

The deadlines for submission of Verified Annual Emissions Report for 2019 emissions (31 March 2020) and surrender of equivalent allowances to 2019 verified emissions (20 April 2020) still apply for participating UK operators.

31 January 2020

The EU ETS will continue for the 2019 and 2020 compliance years during the transition period from 1 February 2020 to 1 January 2021.

5 November 2019

Updated with the latest information on the introduction of the Carbon Emissions Tax.

4 October 2019

Updated with more details on the Carbon Emissions Tax and with more specific information for aviation operators.

9 August 2019

Added summary of actions.

29 July 2019

Updated to confirm start date of the Carbon Emissions Tax; and to update the information on the Kyoto Protocol National Registry.

12 April 2019

The 2018 compliance deadline to surrender allowances for the EU Emissions Trading Scheme (ETS) is 30 April 2019.

The Carbon Emissions Tax will not be commencing on 15 April 2019. Further information on the implications of the extension for carbon pricing will be set out in due course.

29 March 2019

The 2018 compliance deadline to surrender allowances for the EU ETS is 10:59pm on 12 April 2019. If Brexit day is changed again, the compliance deadline will be 30 April 2019 (or immediately before exit in the event that exit day is before 1 May 2019).

11 March 2019

The 2018 compliance deadline to surrender allowances for the EU ETS is being extended from 15 March 2019 to 26 March 2019.

28 February 2019

We have added guidance for UK businesses providing EU ETS verification services to operators in EU countries.


Published: 19th August 2020

Source: GOV UK, Department for Business, Energy & Industrial Strategy

Page URL: https://www.gov.uk/government/publications/meeting-climate-change-requirements-if-theres-no-brexit-deal?utm_source=845f74a1-ec8b-470c-8fbd-ea4ee7adb35f&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Shielding and Statutory Sick Pay (SSP)

Shielding and Statutory Sick Pay (SSP)

Eligibility

To qualify for Statutory Sick Pay (SSP) you must:

  • be classed as an employee and have done some work for your employer
  • earn an average of at least £120 per week
  • have been ill, self-isolating or ‘shielding’ for at least 4 days in a row (including non-working days)

How many days you can get SSP for depends on why you’re off work.

Agency workers are entitled to Statutory Sick Pay.

Telling your employer

You must usually tell your employer you’re unable to work before the deadline they set (or within 7 days if they have not set one).

There is a different deadline if you’re at high risk from coronavirus (COVID-19) and got your NHS or GP letter before 16 April. You must tell your employer by 23 April.

You could lose some of your SSP if you do not tell your employer in time.

Exceptions

You will not qualify if you:

You can still qualify if you started your job recently and you have not received 8 weeks’ pay yet. Ask your employer to find out more.

Linked periods of sickness

If you have regular periods of sickness, they may count as ‘linked’. To be linked, the periods must:

  • last 4 or more days each
  • be 8 weeks or less apart

You’re no longer eligible for SSP if you have a continuous series of linked periods that lasts more than 3 years.

Fit notes and asking for proof

You only have to give your employer a fit note (sometimes called a sick note) if you’re off sick for more than 7 days in a row (including non-working days).

You can get a fit note from your GP or hospital doctor. If your employer agrees, a similar document can be provided by a physiotherapist, podiatrist or occupational therapist instead. This is called an Allied Health Professional (AHP) Health and Work Report.

Proof if you’re self-isolating because of coronavirus

If you’re self-isolating and cannot work because of coronavirus, you can get an ‘isolation note’ online from NHS 111 if you’re off work for 7 or more days. You do not have to go to your GP or a hospital.

If you have a letter from the NHS or a GP telling you to take extra precautions because you’re at high risk of severe illness from coronavirus (known as ‘shielding’), it will include the period you should shield for. The letter is proof of your eligibility for SSP for days away from work in that period.

You may get more than one letter covering more than one shielding period. Contact your GP if you do not have a letter but think you should have one.

If you’ve been notified by the NHS or public health authorities that you’ve come into contact with someone with coronavirus, your notification is proof.

You cannot get SSP if you’re self-isolating after entering or returning to the UK and do not need to self-isolate for any other reason.

If you’re not eligible or your SSP ends

You may be able to apply for Universal Credit or Employment and Support Allowance (ESA). You can use form SSP1 to support your application.

If your SSP is ending your employer must send you form SSP1 either:

  • within 7 days of your SSP ending, if it ends unexpectedly while you’re still sick
  • on or before the beginning of the 23rd week, if your SSP is expected to end before your sickness does

If you do not qualify for SSP your employer must send you form SSP1 within 7 days of you going off sick.


Published: 18th August 2020

Source: GOV UK

Page URL: https://www.gov.uk/statutory-sick-pay/eligibility?utm_source=http%3a%2f%2fnews.dwp.gov.uk%2fdwplz%2f&utm_medium=email&utm_campaign=Coronavirus+Touchbase+special+-+31+July+2020&utm_term=Coronavirus+Touchbase+special+-+31+July+2020&utm_content=56996

WellChild Back to School Webinar and Online Q&A 2020

WellChild Back to School Webinar and Online Q&A 2020

Thursday 20 August 2020 
10:00 AM – 10:45 AM 
Webinar, Online via Zoom 
FREE

Many parents of children with serious health needs have concerns and unanswered questions about
their children returning to school in September. In partnership with North and South Thames Paediatric
Networks, WellChild have organised an online Q&A with a panel of experts from Government, law, health
and education to help answer some of these burning questions.

Hosted by Matt James, WellChild Director of Communications and Engagement, the online event will
take place on Zoom (and will also be broadcast live to the WellChild Family Tree). Details about how to
access the event will be sent out over the coming days.

Click Here to Read More


Published: 18th August 2020

Source: WellChild

Page URL: https://www.wellchild.org.uk/events/back-to-school-webinar/

Getting Clients Home Webinar

Getting Clients Home Webinar

‘Getting Clients Home’ webinar
28th August 2020
10am-1pm

STEPS Rehabilitation are delighted to invite you to their upcoming webinar on Friday 28th August 2020, 10am-1pm.

Ensuring the dignity, well-being and independence of seriously injured individuals following their accident
is something that unites the range of professionals who work in this field. This webinar brings together a
panel of highly respected legal, rehabilitation and architectural experts who will explore a range of topics
and highlight the importance of adopting a collaborative approach to getting clients home.


Speakers include:

Natalie Cosgrove, Solicitor, Switalskis Solicitors (Chair)

Gerard McDermott QC, Outer Temple

Joseph O’Brien, Barrister, St John’s Chambers

Christine Bunting, Director, Hyphen Law

Jonathan France,  Chartered Architectural Professional and Director, France + Associates

Mary Doherty, Specialist Neurological Occupational Therapist, STEPS Rehabilitation

Jennie Foster, Transition of Care Lead, STEPS Rehabilitation


For the full programme please Click Here

To register for the webinar, please email NatalieRodgers@scala.uk.com


Published: 14th August 2020

Source: STEPS Rehabilitation

Page URL: https://www.stepsrehabilitation.co.uk/2020/08/getting-clients-home-webinar-28th-august-2020-10am-1pm/

Office for Life Sciences Bulletin – 14th August 2020

Office for Life Sciences Bulletin – 14th August 2020

The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and
Department for Business, Energy & Industrial Strategy (BEIS).
This bulletin aims to keep the life sciences sector up to date on the latest guidance whilst the UK is in the
transition period and during the Coronavirus (COVID-19) outbreak, providing you with information from
Government to help your members and networks prepare.


Published: 14th August 2020

Source: Office for Life SciencesGOV UK

New Test and Trace App goes into Live Trials

New Test and Trace App goes into Live Trials

A revamped COVID-19 tracker app begins trials today on the Isle of Wight and among NHS volunteer emergency responders.
The London Borough of Newham, which with Brent saw most COVID-19 deaths in the capital at the peak of the pandemic,
will also be a trial site.

Over the coming days, people living on the Isle of Wight will receive a one-time activation code through the post, which will
enable them to download the app. NHS volunteer emergency responders will be contacted by email. 

The app is part of England’s NHS Test and Trace service, and works with both iPhones and Android devices. 

The app will log the time and distance someone has spent near to anyone, even if they don’t know them. If that person later tests
positive for COVID-19, the app will alert them and help them book a test. The app will also give users the risk level in their area
based on their postcode, and if you have to self-isolated it will provide a countdown of the days before you can resume your normal
activities.

Click Here to Read More


Published: 14th August 2020

Source: The Patients Association Newsletter, NHS

Page URL: https://covid19.nhs.uk/

Medway Council Selects Medequip for Community Equipment Services

Medway Council Selects Medequip for Community Equipment Services

Medway Council, which according to research released in February 2020 is one of the highest performing councils in the country for adult social care, has appointed community equipment specialists Medequip to manage CES provision across the area covered by the council including Rochester, Gillingham, Chatham and the Hoo Peninsula.

This is the third CES contract gain announced by Medequip in 2020, which means that the UK’s leading CES provider now manages more than 40 contracts supplying a range of equipment from simple aids for daily living through to more complex pieces of equipment enabling people to receive appropriate care and remain safely in their home environment.

Medequip will also provide Medway Council with advanced equipment management and reporting facilities, using the new TCES Community platform and Microsoft BI reporting capabilities to ensure greater visibility of information and customised reports to match council requirements.

Medequip is currently working with the existing provider to retain the existing depot premises,
supporting minimal disruption to service delivery team members.

“The Medequip team is proud to have been selected by Medway as their chosen partner for the
supply of community equipment,” stated Neil Harris, Medequip’s Implementation Manager for
Medway. “Working with the council, we plan to first evaluate existing service delivery systems,
current community equipment and then, in partnership, begin training and implementation of
new products and an enhanced IT solution. To support the implementation process and going
forward into the future, Medequip will work closely with service users to develop service
provision to best match their needs.”

A recent survey by IMPOWER highlighted Medway as one of 15 councils achieving greater than
average outcomes from a less than average spend per head. This research indicates that
Medway residents using social care are receiving better outcomes, alongside the council
making better use of public funds.

For further information, please contact:-
Medequip Assistive Technology
T:  020 8750 1560
E:  enquiries@medequip-uk.com
W: www.medequip-uk.com


Published: 13th August 2020

Source: Medequip

New Webinar Series Launched for Healthcare Professionals

New Webinar Series Launched for Healthcare Professionals

Safespaces New Webinar Series

A series of online webinars for healthcare professionals has been released by Safespaces
to provide information and guidance on Safespace products and how they can support
adults and children with complex needs.

Developed for healthcare professionals, the webinars will be led by an experienced Product
Advisor who will share their experience, best practice and success stories.
Each session will include a live presentation followed by an interactive Q&A session.

The sessions will be hosted on Zoom and all healthcare professionals are welcome to join!


The webinar series is detailed below.

Tuesday 25th August – 11:00 am

Creating safer environments: An Introduction to Safespace products

This webinar will provide an overview of Safespaces multi-purpose safe room and specialist
high sided bed range. We’ll explore how each product is designed to meet the complex needs
of its users.

Click here to register!

Tuesday 8th September  11:00 am

The Safespace: Challenging Behaviours, Sensory Processing
and Sleep Disorders

Focusing on the Safespace multi-purpose safe room we will explore the key benefits including
improved sleep hygiene, behaviour self-management and how it can be an effective tool to
deliver a sensory diet.

Click here to register!

Tuesday 22nd September 11:00 am

Assessment, Funding and Design: Meeting the Needs

Not sure how to specify a Safespace product for a client? We will talk you through the process
including a joint client assessment, where to obtain funding and the design options available.

Click here to register!

More webinars will be announced soon!


Published: 13th August 2020

Source: Safespaces

Hearing Care Section – 12th August 2020

Hearing Care Section – 12th August 2020

Audiology & Otology Guidance during COVID-19 Pandemic

A letter from BIHIMA Chairman, Paul Surridge, applauding the hearing care industry for its response to the pandemic.


“As we leave lockdown, we at BIHIMA are delighted that audiologists can offer their services once more, giving patients
safe access to the care they provide.

The Covid-19 pandemic has affected all of us in varying ways and our industry is responding admirably, pulling together
to balance the need for provision with patient safety, while keeping infection risk as low as possible for audiologists and
other clinical practitioners.

Lockdown prevented non-urgent medical assessment and treatment and, as it is easing, services are restarting and
patients, who may have been waiting for months to see a practitioner, can now make appointments.

Assessing and treating problems with the senses is a particularly difficult area in terms of viral contamination, with
audiology, dentistry and ophthalmology, amongst others, requiring stringent preventative measures to enable these
industries to return to ‘normal’ service safely. Clear guidance on procedure is critical for practitioners, to prevent the
spread of coronavirus and assure their safety and that of their patients.

BIHIMA welcome the document, Audiology and Otology Guidance during Covid-19, published by AIHHP, BAA, BSA and
BSHAA and appreciate the strength in their collaboration. This comprehensive document provides clear guidance on
giving audiological support during this challenging period: it gives coherent advice on infection-prevention measures
for different procedures and includes a check-list for assessing readiness of face-to-face clinical services.

We applaud the way these four organisations have pulled together at this difficult time to produce such vital guidance
and keep it updated, allowing audiologists to return to work safely and, most importantly, allowing patients to access
the essential care they provide.”

“It has been a struggle for some industries to find a way to offer safe provision, but the hearing loss industry has
triumphed in coming together to develop guidance swiftly.

We would like to thank our fellow associations: AIHHP, BAA, BSA and BSHAA for producing this guidance, and thank all
BIHIMA members, who are working hard to ensure that users of hearing instruments still have access to vital hearing
technology and audiological services.”

Paul Surridge
BIHIMA Chairman


Published: 12th August 2020

Source: BIHIMA (The British Irish Hearing Instrument Manufacturers Association) Newsletter

New Get wise Leaflet to Help Accessing Wheelchair Services

New Get wise Leaflet to Help Accessing Wheelchair Services

BHTA, working with key member companies, has produced a new information leaflet called, “Get wise to Accessing Wheelchair Services (COVID19)”. The information seeks to advise users, on how to access the support available to them, now that many services are returning to work.

The BHTA group members feel that this is a vital next step in driving the key levers that will ensure services can continue to improve, and start to meet the built up demand from users across the country. Users can be confident that their provider and supplier are working together, to reduce the clinical risk involved in these interactions.

The Get wise document is another tool in the return to work programme, and BHTA is delighted, once again, to be working very closely with key providers and suppliers, to ensure that best practice is at the forefront of what is likely to be the new normal.

The New Get wise to Accessing Wheelchair Services can be downloaded by Clicking Here

Andrew Stevenson,
BHTA Chairman


Published: 10th August 2020

Bucking the Trend; BES Invests in R&D Despite the Pandemic

Bucking the Trend; BES Invests in R&D Despite the Pandemic

There are wide spread concerns that the COVID-19 pandemic will leave a “lost generation” in its wake, with many young people not having the employment opportunities that they would have otherwise had. If this does turn out to be the case then it could be one of the greatest losses as a result of the pandemic. Putting this pessimism to one side, BES Healthcare, a local business in Bristol has been doing its part to try and support young and promising people.

This Summer, with University of West of England’s (UWE) support, BES took on two undergraduate students from UWE for a summer internship. This gave the two students, one studying occupational therapy and the other product design, an invaluable opportunity to get some “real world” experience to supplement their course, strengthen their CV, and earn some income.

This summer internship was partly funded by a grant from the university and partly by BES directly, demonstrating how education institutions and private enterprises can work effectively together to deliver valuable employment opportunities despite these challenging times.

Normally when a crisis hits the first things that businesses cut are marketing, R&D, and recruitment. This is an understandable knee jerk reaction; however, it severely compromises a company’s future success. BES bucked the trend this summer and the interns from UWE were taken on to conduct two R&D projects – one to develop PPE for people living with disabilities, and the other to develop the company’s existing specialist seating range for children with disabilities. Along the way BES provided an educational programme covering various aspects of specialist seating and positioning theory, and insights into infection prevention, and the world of international standards and regulations that govern these markets.

Some might think “well it is fine for you as a healthcare business”, sadly not all is at it seems. Certainly, some areas of healthcare have been protected or even boosted by the pandemic, however this isn’t the case across
the piece. BES has seen significant drop offs in business as the NHS has pulled resources into treating COVID
patients, and with service users reluctant to return to healthcare settings for routine treatments and therapies.
Like so many other businesses we have had to rely on various forms of government support to stay afloat, but this
hasn’t meant we can’t simultaneously invest in our future and that of other people.

It was a challenge for both the company and the interns to work effectively under social distancing restrictions,
but solutions could always be found whether it be through video conferencing technology, file sharing and
collaboration software, and carefully controlled meet ups. It also required some out-off-box thinking to overcome
various constraints, for instance we had to keep up production and dispatch but at the same time allow access to
our products and facilities.

BES is very proud to have been able to offer this internship opportunity at such a difficult time with the support of
the university. The interns will take valuable learnings from the experience and be able to strengthen their CVs,
which should serve them well when they graduate. BES has benefited from new product designs that have resulted
from the interns’ work and will be taking these into production in the future. This in turn should benefit multiple
users of this equipment in the future.


Published: 10th August 2020

Source: BES Healthcare Limited

RISE EXPO 2021

RISE EXPO 2021

RISE EXPO MAIDSTONE 2021

Tuesday 22nd June 2021
09:00 – 16:00

Kent Event Centre, Detling Showground, Kent, 
ME14 3JF

RISE is the most comprehensive regional disability
exhibition & conference within the UK. 
Their mission is to unite all disability services. 

Click Here to view the Exhibitor List

Click Here to view the Conference Programme


Published: 10th August 2020

Source: RISE 4 Disability

Page URL: https://rise4disability.com/home

PMG Conference 2021

PMG Conference 2021

PMG conference postponed to 2021 

New dates are Monday, 12th to Wednesday, 14th July 2021
At The International Centre, Telford

Because of all the uncertainties surrounding COVID-19, the PMG Conference has been postponed
from November 2020 to July 2021.

If you want to register at 2020 prices, you can still do so by booking before the extended Early Bird
deadline of 1st October 2020.  When bookings re-open in the New Year, the Early Bird price will
have increased to reflect the higher venue charges PMG will be paying.

To book your place, click here.

For group bookings, click here.

If you want to be kept up-to-date with all the details, make sure you have joined the PMG mailing list.  

General PMG conference information

PMG’s annual conference provides an educational programme, industry exhibition and networking events for professionals working in
the field of posture and wheeled mobility. The majority of the delegates are occupational therapists, physiotherapists, rehabilitation
engineers and clinical scientists working within the NHS wheelchair services or for manufacturers/distributors of posture and mobility
products, with a smaller, but significant, number working in other NHS departments, the charitable sector, for local authorities, or
independently.

The event focuses on the posture and mobility needs of wheelchair users and, as such, is beneficial for all professionals working in this
field.
Much of the content provided is also transferrable to other complex seating needs, and therefore we welcome professionals working
within the community, whose focus is not exclusively wheelchairs.

If you have general questions about the conference, please email olwen.ellis@pmguk.co.uk.

For enquiries about stand bookings or attending as a delegate, please contact pmgbookings@conferencecollective.co.uk 

To book your place, click here.

For group bookings, click here.


Published: 10th August 2020

Source: PMG Conference

Page URL: https://www.pmguk.co.uk/conference

Get wise to Accessing Wheelchair Services (Covid-19)

Get wise to Accessing Wheelchair Services (Covid-19)

Medical Devices: Software Applications (Apps)

Medical Devices: Software Applications (Apps)

Information on when software applications are considered to be a medical device and how they are regulated.

Guidance on what a software application medical device is and how to comply with the legal requirements.

Read the statement on the launch of the guidance

For full functionality, this document is best viewed in Acrobat reader.


Published: 8th August 2020

Source: GOV UK, Medicines and Healthcare products Regulatory Agency

Page URL: https://www.gov.uk/government/publications/medical-devices-software-applications-apps

Moving Goods under the Northern Ireland Protocol

Moving Goods under the Northern Ireland Protocol

This guidance provides support for businesses engaging in new processes under the Northern Ireland protocol.

Moving Goods under the Northern Ireland Protocol

Moving Goods under the Northern Ireland Protocol – Section One:
Moving Goods from Northern Ireland to Great Britain

Moving Goods under the Northern Ireland Protocol – Section Two:
Moving Goods from Great Britain to Northern Ireland

Moving Goods under the Northern Ireland Protocol – Section Three:
Moving Goods from Northern Ireland to the European Union

Moving Goods under the Northern Ireland Protocol – Section Four:
Moving Goods from Northern Ireland to the rest of the world

At the end of the transition period, the Northern Ireland Protocol (‘the Protocol’) will take effect. The Protocol is a
practical solution to avoid a hard border with Ireland whilst ensuring the UK, including Northern Ireland, leaves the
EU as a whole, enabling the entire UK to benefit from future Free Trade Agreements. There will be special provisions
which apply only in Northern Ireland while the Protocol is in force.


Published: 7th August 2020

Source: GOV UK, Cabinet Office

Page URL: https://www.gov.uk/government/publications/moving-goods-under-the-northern-ireland-protocol?utm_source=fbffa280-90ca-4d09-b49b-f2983613217a&utm_medium=email&utm_campaign=govuk-notifications&utm_content=daily

Office for Life Sciences Bulletin – 7th August 2020

Office for Life Sciences Bulletin – 7th August 2020

The Office for Life Sciences (OLS) is a joint unit between the Department of Health & Social Care (DHSC) and Department for Business, Energy & Industrial Strategy (BEIS).
This bulletin aims to keep the life sciences sector up to date on the latest guidance whilst the UK is in the transition period and during the Coronavirus (COVID-19) outbreak, providing you with information from Government to help your members and networks prepare.


Published: 7th August 2020

Source: Office for Life SciencesGOV UK

Moving Goods into, out of, or Through Northern Ireland from 1st January 2021

Moving Goods into, out of, or Through Northern Ireland from 1st January 2021

What UK businesses can do now to get ready for 2021.

The Northern Ireland Protocol

The Northern Ireland Protocol to the Withdrawal Agreement was designed as a practical solution to avoid a hard border on the island of Ireland,
whilst ensuring that the UK, including Northern Ireland, could leave the EU as a whole.

The UK’s approach to the Northern Ireland Protocol outlines how the protocol can be implemented in a way that would protect the interests of
the people and economy of Northern Ireland, ensure the effective working of the UK’s internal market, provide appropriate protection for the EU
Single Market and uphold the rights of all Northern Ireland’s citizens.

Until negotiations with the EU conclude, there will be some areas without complete certainty, but full guidance will be provided by the end of the
transition period.


Published: 7th August 2020

Source: GOV UK, Cabinet OfficeNorthern Ireland Office, and Government Digital Service

Page URL: https://www.gov.uk/guidance/moving-goods-into-out-of-or-through-northern-ireland-from-1-january-2021?utm_source=66882189-a560-4ea2-992c-50f1f4da2a15&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Register an Interest in the Trader Support Service

Register an Interest in the Trader Support Service

Find out how you can register an interest in the Trader Support Service and keep up to date with other changes due to the implementation
of the Northern Ireland Protocol.

At the end of the transition period when the Northern Ireland Protocol comes into force there will be changes to the way goods move between
Great Britain and Northern Ireland.

If your business is impacted by these changes, you may want to consider the Trader Support Service. It can help you if you:

  • move goods between Great Britain and Northern Ireland, or bring goods into Northern Ireland from outside the UK
  • act on behalf of someone to move goods between Great Britain and Northern Ireland, or bring goods into Northern
    Ireland from outside the UK
  • are based in Northern Ireland and receive goods from outside of Northern Ireland
  • send parcels between Great Britain and Northern Ireland, or bring parcels into Northern Ireland from outside the UK,
    using Royal Mail or an express operator

The Trader Support Service will be free to use and will guide you through any changes to the way goods move between Great Britain and
Northern Ireland, and into Northern Ireland from outside the UK. You can also use it to get declarations completed on your behalf.
Further information is available for UK businesses moving goods into, out of, or through Northern Ireland.

To register an interest in the Trader Support Service, fill in the form below, save it, then email it to: hmrctraders@hmrc.gov.uk.

This will also help us identify businesses that currently move goods between Great Britain and Northern Ireland.


Published: 7th August 2020

Source: GOV UK, HM Revenue & Customs

Page URL: https://www.gov.uk/guidance/trader-support-service

Major £650 Million Investment for Northern Ireland

Major £650 Million Investment for Northern Ireland

Chancellor of the Duchy of Lancaster, Michael Gove, and the Secretary of State for Northern Ireland, Brandon Lewis,
announce a major £650m package of investment.

  • A new free-to-use Trader Support Service backed by funding of up to £200 million will complete digital processes on behalf of
    businesses importing goods into Northern Ireland.
  • £155m to fund the development of new technology to ensure the new processes can be fully digital and streamlined.
  • £300 million confirmed funding for the PEACE Plus programme will help to support peace, prosperity and reconciliation projects
    on the island of Ireland.

On a visit to Northern Ireland today (Friday 7 August), Chancellor of the Duchy of Lancaster, Michael Gove, and the Secretary
of State for Northern Ireland, Brandon Lewis, will announce a major £650m package of investment to help traders in Northern
Ireland, and support peace, prosperity and reconciliation projects on the island of Ireland.

At the centre of this package is a new, free-to-use Trader Support Service (TSS) – an end-to-end support service to deal with
import and safety and security declarations on behalf of traders.

The new service will be available to businesses bringing in goods from Great Britain or the rest of the world, providing
guidance as well as dealing with their requirements for moving goods into Northern Ireland.

A procurement exercise for the service has now been launched. We have committed £50m of funding for the establishment
and first phase of the service, with the full contract to be worth up to £200m. Businesses in Northern Ireland can sign up for
further information about the scheme on GOV.UK from today, before it becomes operational in September.

The service is outlined as part of the publication of new guidance on the Northern Ireland Protocol for businesses moving
goods into and from Northern Ireland. The new online pages have been added to gov.uk/transition and will be updated as
implementation work and UK-EU discussions proceed as part of the Withdrawal Agreement Joint Committee.
This provides further clarity to businesses following the publication of the Government’s Command Paper in May, with
additional details to be outlined as work proceeds in the coming months to support preparations for the end of the transition
period.

The Chancellor of the Duchy of Lancaster and the Secretary of State also confirmed £300m of funding to the PEACE Plus
programme to support peace and reconciliation across the island of Ireland.


Chancellor of the Duchy of Lancaster, Michael Gove, said:

Today’s £650 million investment underlines our absolute commitment to the people and businesses of Northern Ireland as
we move towards the end of the transition period.

Our new free-to-use Trader Support Service will provide vital support and guidance to traders, while our £300 million
investment in reconciliation projects will help to preserve the huge gains from the peace process and the Belfast
(Good Friday) Agreement.

As part of our ongoing engagement with Northern Ireland businesses and the Executive, we are also publishing further
guidance for businesses on the operation of the Protocol.

As we continue to engage with businesses and our discussions with the EU proceed, we will update these resources to
ensure that traders are ready for the end of the transition period.


The Secretary of State for Northern Ireland, Brandon Lewis, said:

Businesses have always been at the heart of our preparations for the end of the transition period. This new Trader Support
Service backed by funding of up to £200m reinforces this approach – it is a unique service that will ensure that businesses
of all sizes can have import processes dealt with on their behalf, at no cost.

We recognise the importance of clarity and certainty for businesses which is why, as our discussions with the EU continue,
the Business Engagement Forum will remain a vital forum to bring together the UK Government and the NI Executive with
businesses across NI and their representatives to make sure they have the information they need to support their preparations.

We also recognise that the Protocol is about more than maintaining the critical economic links that exist across our
United Kingdom, so I am proud that we have committed to provide £300 million to the PEACE Plus programme, which
does such important work across the island of Ireland to promote peace and reconciliation.


Published: 7th August 2020

Source: GOV UK, Cabinet OfficeNorthern Ireland OfficeThe Rt Hon Michael Gove MPThe Rt Hon Brandon Lewis MP

Page URL: https://www.gov.uk/government/news/major-650-million-investment-for-northern-ireland?utm_source=62f89f14-f03f-4e34-9e20-b1bad60f9a28&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Importing and Exporting Healthcare and Assistive Technology Today and Post Transition

Importing and Exporting Healthcare and Assistive Technology Today and Post Transition
Importing and Exporting Healthcare and Assistive Technology Today and Post Transition

Host: William Barns Graham
Senior Content Editor
Institute of Export & International Trade

Presenter: Kevin Shakespeare
Director of Stakeholder Engagement
Institute of Export & International Trade


With the growing global demand for healthcare, assistive technology and PPE, the Institute of Export and International Trade and British Healthcare
Trades Association are pleased to provide a masterclass on ‘Importing and exporting healthcare and assistive technology’. In 2020 traders in this
sector have been faced by the rising demand and logistical challenges posed by the coronavirus pandemic. Following the end of the transition period
on 31 December 2020, importers and exporters will faces new challenges and opportunities as rules for trade with the EU will change. International
trade must always be carried out effectively and compliantly to ensure reliability and security of supply, both today and in 2021. During this 1-hour
webinar you will learn: – An analysis of the types of goods which are classified as Healthcare, Assistive Technology and PPE – Effective international
trading processes – Trade and product compliance – today and from 2021, post-transition – Trading opportunities A recording will be made available
after the webinar, and you can ask questions in advance via the registration form below.


Published: 6th August 2020

Video URL: https://www.youtube.com/watch?v=RV_6o43cO-c&feature=youtu.be

The Care Summer Series

The Care Summer Series

The Care Summer Series is a FREE two day digital event on the 10th & 11th August.

About The Care Summer Series:

The two days will host educational webinars, led by experts in the care sector.

The aim of this digital event is to bring the whole community together and celebrate
the care sector – no matter where we all are.

Key webinar themes include: the future deal for social care, funding, raising the
quality of care in the new normal, promoting integrated care, raising the profile of
home care, new care models going forward, and supporting the care workforce.

Click Here for more information


Published: 6th August 2020

Practical Steps to Support Safe Working and Prevent and Mitigate COVID-19 Outbreaks in your Organization

Practical Steps to Support Safe Working and Prevent and Mitigate COVID-19 Outbreaks in your Organization

The current COVID-19 pandemic has fundamentally shifted the way people live
and work. As the pandemic spread and began to impact different regions, many
countries faced a sudden ‘lockdown’. With populations confined to their own
homes, organizations of all types had to change the way they operated or shut
down entirely, with little or no time to prepare. Following the initial global crisis,
a potential cycle is emerging: outbreaks are controlled and restrictions are eased,
new clusters of cases emerge and restrictions need to be reintroduced.


Published: 5th August 2020

Source: bsi (British Standards Institution)

Future Planning of Personal Protection Equipment (PPE) Supply

Future Planning of Personal Protection Equipment (PPE) Supply

The PPE Demand & Strategy team at the Department of Health and Social Care is looking at the use of PPE
across the social care sector in order to inform future planning. The feedback deadline is the 7th August.

Further info: https://lnkd.in/etMZ5Wp

Spreadsheets: https://lnkd.in/ezCxmGC


Published: 5th August 2020

Source: United Kingdom Homecare Association Ltd (UKHCA) Linked-In

Roll-out of 2 New Rapid Coronavirus Tests ahead of Winter

Roll-out of 2 New Rapid Coronavirus Tests ahead of Winter

Millions of new rapid coronavirus tests will be rolled out across NHS hospitals, care homes and labs from next week.

  • Both tests will be able to detect COVID-19 and other winter viruses in just 90 minutes
  • New tests will hugely increase testing capacity ahead of winter, delivering fast results that will help to break chains of transmission quickly

Millions of ground-breaking rapid coronavirus tests will be rolled out to hospitals, care homes and labs across the UK to increase testing capacity ahead of winter. The tests will enable clinicians and NHS Test and Trace to quickly advise on the best course of action to stop the spread of the virus.

Two new tests – both able to detect the virus in just 90 minutes – will be made available to NHS hospitals, care homes and labs. The 2 tests will be able to detect both COVID-19 and other winter viruses such as flu and respiratory syncytial virus (RSV). The tests do not require a trained health professional to operate them, meaning they can be rolled out in more non-clinical settings.

This will help to further strengthen the coronavirus response this winter, arming both clinicians and NHS Test and Trace with the ability to distinguish between COVID-19 cases, which have specific self-isolation requirements, and other winter viruses.

Health Secretary Matt Hancock said:

We’re using the most innovative technologies available to tackle coronavirus. Millions of new rapid coronavirus tests will provide on-the-spot results in under 90 minutes, helping us to break chains of transmission quickly.

The fact these tests can detect flu as well as COVID-19 will be hugely beneficial as we head into winter, so patients can follow the right advice to protect themselves and others.

I am hugely grateful for the excellent work done by DnaNudge and Oxford Nanopore to push forward these life-saving innovations in coronavirus testing.

A new test that uses DNA to detect the virus will be rolled out across NHS hospitals from September, with 5,000 DNA machines, supplied by DnaNudge, to provide 5.8 million tests in the coming months.

Separately, 450,000 90-minute LamPORE swab tests will also be available across adult care setting and laboratories from next week, supplied by Oxford Nanopore.

DNA testing for coronavirus

5,000 DNA ‘Nudgebox’ machines, supplied by DnaNudge, will be rolled out across NHS hospitals in the UK to analyse DNA in nose swabs, providing a positive or negative result for COVID-19 in 90 minutes, at the point of care. The machines will process up to 15 tests on the spot each day without the need for a laboratory.

The DNA COVID-19 test machines are currently operating in 8 London hospitals:

  • St Mary’s Hospital in Paddington
  • Charing Cross Hospital
  • West Middlesex University Hospital
  • Chelsea and Westminster Hospital
  • Royal Hospital Chelsea
  • Queen Charlotte’s and Chelsea Maternity Hospital
  • the Renal Transplant Centre at Hammersmith Hospital
  • the Tower Hamlets Centre for Mental Health at Mile End Hospital

The machines are located in cancer wards, A&E and maternity wards to protect those most at risk.

The government is signing contracts with more companies to produce machines for DNA coronavirus testing.

Rapid LamPORE tests

The new rapid LamPORE test will be able to process swab and saliva samples to detect the presence of COVID-19 in 60 to 90 minutes.

The new test has the same sensitivity as the widely used PCR swab test, but can be used to process swabs in labs, as well as on-location through ‘pop up’ labs. The desktop GridION machine can process up to 15,000 tests a day, or the palm-sized MinION can process up to 2,000 tests a day for deployment in a near-community ‘pop-up’ lab.

450,000 of the new LamPORE tests will be available from next week across adult care settings, NHS laboratories and lighthouse laboratories, with millions more tests to be rolled out later in the year.

Details of positive test results will be shared with NHS Test and Trace, so close contacts can self-isolate in line with guidance.

Regius Professor Chris Toumazou FRS, CEO and co-founder of DnaNudge and founder of the Institute of Biomedical Engineering at Imperial College London, commented:

The DnaNudge team worked with incredible speed and skill during the peak of the pandemic to deliver this highly accurate, rapid COVID-19 test, which requires absolutely no laboratory or pipettes and can be deployed anywhere with a direct sample-to-result in around just over an hour.

We have been able to successfully adapt our in-store consumer DNA testing technology – which identifies genetic risks for chronic conditions related to obesity and type 2 diabetes – and validate it for detecting COVID-19 with gold-standard accuracy.

We are extremely proud to be playing such a pivotal role in supporting the national effort on testing, as this major contract award signifies. With the ability to test not only for COVID-19 but also FluA, FluB and RSV on the same single COVID-19 Nudge cartridge, our multiplex test offers a vital solution to protect the NHS as we head into the flu season.

Gordon Sanghera, CEO of Oxford Nanopore, said:

We are honoured to be playing a part in fighting COVID-19 in the UK, and preparing the country for the winter virus season. Ever since we founded Oxford Nanopore, our mission has been to create disruptive, high performance technology that has a profound, positive impact on society.

LamPORE has the potential to deliver a highly effective and, crucially, accessible global testing solution, not only for COVID-19 but for a range of other pathogens. We are delighted to be working with the UK government to support and empower our communities to effectively manage testing at a national and localised level.

Background information

About DnaNudge

DnaNudge, based in London, is a retail based, on-the-spot genetic testing service that provides product recommendations suited to your DNA to promote a healthy lifestyle.

DnaNudge’s new RNA COVID-19 tests are based on DnaNudge DNA testing innovation delivering processing outside of a laboratory environment, using DnaNudge’s patented and miniaturised ‘NudgeBox’ analyser, which can be used anywhere.

About Oxford Nanopore

Oxford Nanopore, which last year built a factory in Oxfordshire, is a rapidly growing business that is scaling its operations to be able to provide substantial volumes of tests to the UK – critical to support expanded testing at a time when global supply chains are squeezed for traditional tests.

About LamPORE

LamPORE uses a method called RT-LAMP to identify and amplify the SARS-CoV-2 virus in an original sample, and Oxford Nanopore’s sequencing technology to precisely identify the amplified virus. It tests for active infection, providing a complementary testing solution to antibody detection, currently only able to indicate a previous infection.

LamPORE includes a control mechanism that detects and invalidates samples where there has been an error in sample collection.


Published: 3rd August 2020

Source: GOV UK, Department of Health and Social Care

Page URL: https://www.gov.uk/government/news/roll-out-of-2-new-rapid-coronavirus-tests-ahead-of-winter

Continuity of the Supply of Medicines and Medical Products to the UK

Continuity of the Supply of Medicines and Medical Products to the UK

This writing is intended to share information with you on the end of the Transition Period (TP) on 31 December 2020 as it relates to the continuity of the supply of medicines and medical products to the UK.
This follows the Government’s recent confirmation that the TP will cease as planned on 31 December 2020 and there will be no extension.


Published: 3rd August 2020

Source: Department of Health and Social Care Newsletter

How Healthcare Providers can Prepare for 1st January 2021

How Healthcare Providers can Prepare for 1st January 2021

What providers and commissioners of healthcare services can do to prepare for 1 January 2021.

This guidance sets out the actions that healthcare providers should take to prepare for 1 January 2021. Doing this will help to plan for and
manage potential service disruption to healthcare.

This guidance is for commissioners and healthcare providers, including hospitals, care homes, GP practices and community pharmacies.

You can also see guidance for adult social care providers.

Supply of medical products

Read about the government’s plan to introduce import controls on EU goods after 31 December 2020.

The government has already announced it will implement new border controls in 3 stages leading up to full implementation in July 2021.
Details are set out in the Border Operating Model, published on 13 July 2020.

If you have any questions, you can contact the relevant government team for your sector:

Business continuity plans

Make business continuity and contingency plans and review them regularly. Keep the plans up to date and consistent with other local
contingency plans, in particular those being developed by your local resilience forum.

Make sure you also have plans in place for the months after 31 December 2020 to ensure continuity of care for service users.

Workforce

Actions:

  • review your capacity and activity plans regularly.
  • make sure your business continuity plans cover the supply of staff you need to deliver services before and after 31 December 2020
  • you don’t need to change existing EU staff employment contracts
  • you must notify your local commissioner as soon as possible if there is any risk to service delivery

The EU Settlement Scheme

Tell any staff who are EU citizens about the EU Settlement Scheme. Help staff to apply if they need support.

Through the EU Settlement Scheme, EU nationals can register for settled status if they have been in the UK for 5 years or pre-settled
status if they have been here for less than 5 years.

The scheme is free and it’s simple to register. The deadline for applications is 30 June 2021.

Irish citizens are not required to apply for the EU Settlement Scheme, although there are some circumstances where they may wish to.
Non-Irish family members of Irish citizens will need to apply.

Recognition of professional qualifications

EEA and Swiss health and care professionals who are registered and practising before 1 January 2021 will continue to be able to do so
from 1 January 2021.

For any professional registration queries, please contact the relevant professional regulator.

EU Third Health Programme

Successful bids for EU funding from the Third Health Programme made before 31 December 2020 will receive their full financial allocation
for the lifetime of the project or joint action.

Help and contacts

Help with developing business continuity and contingency plans

If you need support in developing a business continuity plan or contingency plan, contact your local commissioner or contacts within your
local authority.

Help with workforce queries

Raise concerns about capacity and resourcing in the usual way.

It is important to tell your local commissioner and the Care Quality Commission as soon as possible if there is any risk to service delivery.

Help with supply of medicines and vaccines

Continue to manage medicine and vaccine supply issues in the way you usually do.

Report concerns about supply issues through your regional pharmacist.

Help with supply of medical devices, clinical consumables and
non-clinical goods and services

Start by following your usual processes. Check with your supplier or other relevant teams in your organisation.

Check with your clinical lead if you can use a different brand or product. If you can use an alternative but you are concerned about the
initial shortage, report it through your usual escalation channels. This will ensure that supply can be restored as quickly as possible.

Tell your local commissioner and the Care Quality Commission as soon as possible if disruption to the supply of medical devices, clinical
consumables and/or non-clinical goods and services poses a risk to service delivery.

This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes. For current information, read:
You can also read about the transition period.


Published: 3rd August 2020

Source: GOV UK, Department of Health and Social Care

Page URL: https://www.gov.uk/guidance/how-healthcare-providers-can-prepare-for-brexit?utm_source=0e1026bc-a981-446a-ad36-9702a2d44e6d&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

Government Contacts to Help Medical Supply Businesses After 31 December 2020

Government Contacts to Help Medical Supply Businesses After 31 December 2020

Government contacts that supply businesses can use to keep medical products flowing into the UK after 31 December 2020.


Import controls

Read about the government’s plan to introduce import controls on EU goods after 31 December 2020.

Business can prepare for border controls by making sure they have an Economic Operator Registration and Identification
(EORI) number and looking into how they want to make declarations, such as using a customs agent.

The government will ensure the facilitation currently available to rest-of-world traders will also be open to those trading
between Great Britain and the EU.

The government has already announced it will implement new border controls in 3 stages leading up to full implementation in
July 2021. Details are set out in the Border Operating Model, published on 13 July 2020.


Contacts
If you have any questions about ensuring the flow of medical supplies into the UK after 31 December 2020, you can contact
the relevant government team for your sector:

This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes.
For current information, read: Reporting requirements for medicine shortages and discontinuations
You can also read about the transition period.


Published: 3rd August 2020

Source: GOV UK, Department of Health and Social Care

Page URL: https://www.gov.uk/guidance/government-services-to-help-medical-supply-businesses-manage-brexit?utm_source=c461308a-46bc-4471-8325-ddb23f633caa&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate