Last Updated on 26/10/2020 by Millie York
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:
This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
For Northern Ireland, different rules will apply to those in Great Britain after the end of 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’
In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices.
This guidance only applies to medical devices and does not cover other CE marked 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.
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:
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 has ended.
This means that from 1 January 2021, the Great Britain route to market and UKCA marking requirements will continue to be based on the requirements derived from current EU legislation.
The EU MDR and EU 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, they will not be EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain. This means that the provisions contained within the EU MDR and EU IVDR will not be transposed into law in Great Britain and will not be implemented 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 prioritises patient safety. 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 on this proposed regime. As part of these discussions, we will identify and prioritise elements of international practice that promote public health and patient safety. 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 EU MDR or the EU IVDR will be regulated.
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 devices 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.
From 1 January 2021, the roles and responsibilities of those manufacturing and supplying medical devices, including IVDs, will change.
Manufacturers wishing to place a device on the Great Britain market will first need to register with the MHRA. See guidance on registrations below for more information.
Where a manufacturer is not established in Great Britain, they will need to appoint a UK Responsible Person to register and act on their 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.
After the transition period, any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market. This will apply to devices of all classes. In Great Britain, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA.
The MHRA will only register devices where the manufacturer or their UK Responsible Person has a registered place of business in the UK. If the manufacturer is based outside the UK, they will need to appoint 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.
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. These registration requirements will not apply until after the transition period.
The following devices must be registered with the MHRA from 1 May 2021:
The following devices must be registered with the MHRA from 1 September 2021:
The following devices must be registered with the MHRA from 1 January 2022:
It will be possible to register devices ahead of the above dates, but there will be no legal obligation to do so.
Where a medical device is already registered with the MHRA, it will not need to be re-registered after 1 January 2021. However, manufacturers (or their UK Responsible Person) will be required to review the information held by MHRA to ensure it remains correct in line with the above grace periods.
Where any changes to registrations are made, a £100 standard fee will apply per application.
It will be possible for manufacturers to register devices of different classes, that are subject to different grace periods, at the same time. For example, manufacturers (or their UK Responsible Person) will be able to register their Class IIa medical devices at the same time as registering their Class III medical devices. In this particular case, devices would need to be registered from 1 May 2021 in line with the grace period for registering Class III devices.
Registration for custom-made devices will be in line with the risk class of the device. Failure to register from these dates will mean that you will no longer be able to lawfully place your device on the Great Britain market.
Manufacturers of Class I devices, custom-made devices and general IVDs that are currently required to register their devices with the MHRA must continue to register their devices on the same basis as they do now until the new registration requirements start to apply to those devices.
If you are a Northern Ireland-based manufacturer and have already registered your device with the MHRA for the purposes of Northern Ireland, it can then be placed on the Great Britain market and will not need to undergo any further registration in Great Britain.
Further information on registration requirements for Northern Ireland is provided below.
More information on registrations (including fees) can be found in the MHRA’s registrations guidance. The registrations guidance page will be updated with further detailed guidance in due course.
As noted above, to place a device on the Great Britain market, manufacturers based outside the Great Britain will be required to appoint a UK Responsible Person that is established in the UK. Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately below. Importers and distributors will not be required to appoint a UK Responsible Person.
Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. The UK Responsible Person will then need to register relevant devices with the MHRA in line with the above grace periods depending on the device class.
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 the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain 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, in addition to the above registration requirements, the UK Responsible Person must:
It will be possible for an importer or distributor to act as a UK Responsible Person.
From 1 January 2021, the name and address of the UK Responsible Person, where applicable, will need to be included on product labelling where the UKCA mark has been affixed. UK Responsible Person details will not need to be included on labelling for CE marked devices.
In cases where the Great Britain importer is not the UK Responsible Person, the importer will be required to inform the relevant UK Responsible Person of their intention to import a device. In such cases, the UK Responsible Person will be required to provide the MHRA with a list of device importers. We will provide further guidance in due course.
Other than the above requirement, there will be no additional obligations on distributors or suppliers of medical devices as of 1 January 2021. Existing obligations around storage, transportation and checking device labels for the CE marking or UKCA marking will continue to apply. The importer’s name and address will not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person. We will consult on any future changes to this.
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 marking for sale in these markets.
Manufacturers will be able to use the UKCA mark on a voluntary basis from 1 January 2021.
Where third party conformity assessment is required, a UK Approved Body will be needed. However, Class I device manufacturers will be able to self-certify against the UKCA mark from 1 January 2021.
See the guidance Using the UKCA mark from 1 January 2021 for further information.
UKCA mark requirements will continue to be based on the requirements of the relevant Annexes to the Directives listed below, which are given effect in UK law through the UK MDR 2002:
From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.
From 1 January 2021, the MHRA will be able to designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark.
Existing UK Notified Bodies with designations under the EU MDD, EU IVDD or EU AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
For the purposes of the Great Britain market, UK Approved Bodies will only be able to conduct conformity assessments in relation to the UKCA mark, 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). UK Approved Bodies will not be able to conduct conformity assessments in relation to the CE marking other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland. Please see guidance below on Northern Ireland for further information.
The government is setting up a new domestic UK database to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System.
See the guidance Conformity assessment bodies: change of status from 1 January 2021 for further information.
Manufacturers of Class I medical devices and general IVDs will be able to self-declare their conformity against the EU MDD or EU IVDD as transposed by 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 a UK Approved Body in order to be affixed with the UKCA mark and placed on the Great Britain market.
We will continue to accept CE marked devices on the Great Britain market until 30 June 2023. This will apply to devices 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.
Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023.
From 1 January 2021 any mandatory third-party conformity assessment for the CE marking will need to be carried out by an EU-recognised Notified Body. This includes both EU-based Notified Bodies and Notified Bodies in countries which are listed on the EU’s NANDO Information System.
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 marking continues to be recognised in Great Britain (until 30 June 2023). This will include devices placed on the market that are:
Therefore, any enforcement or market surveillance powers available in respect of the UKCA mark will apply to CE marked devices placed on the Great Britain market. Where certificates have been issued by a UK Notified Body, the Notified 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
As of 1 January 2021, medical devices placed on the Great Britain market will need to have either a UKCA mark or a CE marking, 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 marking 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. Devices can have both marks present on the labelling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023. However, from 1 January 2021 the name and address of the UK Responsible Person, where applicable, will need to be included on product labelling where the UKCA mark has been affixed (including when devices have been dual marked).
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.
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, in most cases, to register devices with the MHRA and have a UK Responsible Person if the manufacturer is based outside the UK, as set out below.
From 1 January 2021, the following requirements will apply to manufacturers placing medical devices on the Northern Ireland market:
Unlike Great Britain, 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.
Although the UKCA mark will be available for use in Great Britain from 1 January 2021, a CE marking 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 from 1 January 2021 for the purposes of the Northern Ireland market.
From 1 January 2021, to place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK Notified Bodies will not be recognised within the EU.
UK Notified Bodies will be able to conduct conformity assessments for the purposes of the Northern Ireland market.
In addition to the CE marking, device manufacturers will also need to apply the UKNI marking if they choose to use a UK Notified Body for mandatory third-party conformity assessment. Device manufacturers will never apply the UKNI marking on its own – it will always accompany a CE marking. To place goods on the EU market, manufacturers must use the CE marking on its own, without the UKNI marking. Goods bearing the “CE & UKNI” marking will not be accepted on the EU market.
In summary, you need to use the UKNI marking if:
The UKNI marking is sometimes referred to as the UK(NI) mark or the UK(NI) indication, including in Article 7(3) of the Northern Ireland Protocol. These terms refer to the same marking.
Further guidance on applying the UKNI marking will be available in due course.
After the transition period, most medical devices, IVDs and custom-made devices that are placed on the Northern Ireland market will need to be registered with the MHRA. Registration requirements will be subject to grace periods. The precise requirements will depend on the location of the manufacturer, the location of the Authorised Representative and the device class, as set out below. Please see the MHRA’s guidance on registrations for more information.
You will need to appoint a UK Responsible Person within the UK by 1 January 2021 for devices that are placed on the Northern Ireland market if you are an EU or EEA-based manufacturer. If you are a third country manufacturer that has an Authorised Representative based in the EU, you will also be required to appoint a UK Responsible Person.
The requirement to appoint a UK Responsible Person will not apply where:
Great Britain manufacturers will be required to appoint an Authorised Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market. Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative will need to register all device classes with the MHRA. Where an EU-based Authorised Representative is appointed, the manufacturer will need to register all device classes other than Class I devices, custom-made devices and general IVDs with the MHRA.
It will be possible for a single entity to act as both an Authorised Representative based in Northern Ireland and a UK Responsible Person.
The timelines for registering medical devices with the MHRA are set out below. Where applicable, Class I devices, custom-made devices and general IVDs must be registered from 1 January 2021. For other device classes there will be grace periods for registering as follows:
These new registration requirements will not apply until 1 January 2021 and, as noted, will be subject to the above grace periods.
In cases where the Northern Ireland importer is not the Northern Ireland-based Authorised Representative or the UK Responsible Person, the importer will be required to inform the relevant Northern Ireland-based Authorised Representative or UK Responsible Person of their intention to import a device. In such cases, the Northern Ireland-based Authorised Representative or UK Responsible Person will be required to provide the MHRA with a list of device importers.
The UK Government will guarantee unfettered access for Northern Ireland’s businesses to the rest of the UK internal market from 1 January 2021.
For medical devices, this means that any conformity mark held by a Northern Ireland business which validates a device for sale on the Northern Ireland market will be valid for the whole of the UK market. Therefore Northern Ireland businesses will be able to continue to place CE and CE UKNI marked devices on the Great Britain market after 30 June 2023.
In addition, if you are a Northern Ireland-based manufacturer and have already registered your device with the MHRA for the purposes of Northern Ireland, it can then be placed on the Great Britain market and will not need to undergo any further registration in Great Britain.
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.
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 marking to demonstrate compliance.
The UKCA marking will not be recognised on the EU market. Products currently requiring a CE marking will still need a CE marking for sale in the EU from 1 January 2021.
If you use a UK-based Notified Body to conduct any mandatory third-party conformity assessment for your device, the following will apply:
The results of mandatory conformity assessment carried out by UK Notified 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 you will need to use an EU-recognised Notified Body where mandatory third party conformity assessment is required.
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:
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 appoint 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 appoint an Authorised Representative based in the EU or Northern Ireland, to register and act on your behalf.
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. Both the CE and UKCA mark can be placed on a product so long as neither impedes the visibility of the other and both marking requirements are met. Devices placed on the Northern Ireland market from 1 January 2021 will also need to meet EU labelling requirements. However, such devices will need to be affixed with a CE UKNI mark if mandatory conformity assessment has been undertaken by a UK Notified Body.
Please direct any queries to devices.regulatory@mhra.gov.uk.
Published: 21st October 2020
Source: GOV UK, Medicines and Healthcare products Regulatory Agency
Page URL: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
