Last Updated on 16/12/2022 by Jamie McKay
NB: Brexit uncertainties, the Covid-19 pandemic, and turbulent change – of UK political leaders, officials, and policy directions – have all clouded the future of medical devices in the UK. To provide as much clarity as possible, BHTA is attempting to assimilate updates and information from MHRA, Government, companies, and other sector stakeholders.
The contents of the BHTA website do not constitute legal advice, and are provided for information purposes only: BHTA disclaims and excludes any liability in respect of the contents, or for action taken based on this information.
Sources: MHRA / Trade Association Liaison Meetings (monthly); BHTA / MHRA Queries (ad hoc); BHTA / Member conversations (ad hoc)
1. Will MHRA provide guidance for “on-the-ground” operation of the new regulations under the new medical device regime?
Previous updates
08-Aug-22:
Yes – MHRA’s legal team is in the process of drafting both the regulations for the new regime and guidance thereon. Once published, there will be a six-month period that will elapse before the regulations can come into force. The stated timeline for sharing the first draft(s) of the guidance on the regulations is four-to-six weeks from now, with MHRA pledging to schedule a publicly-accessible webinar to introduce the new regulations and guidance “sometime in September 2022.” BHTA will share the details of this webinar once MHRA announces the date/time.
05-Oct-22:
The release of the regulations and guidance has been delayed; they are now unlikely to appear until sometime after Nov-22 (please see item 4 below for additional detail).
31-Oct-22:
MHRA announced in their 21-Oct-22 letter the UK Government decision to re-set the implementation of new UK medical device regulations to 01 July 2024, from its most-recently-planned date of 01 July 2023. It seems clear that MHRA intends this as a “Letter of Comfort” to provide medical device stakeholders – companies, UK CABs, EU NBs, and others – written confirmation of the UK’s intent regarding new law and regulation. One of MHRA’s next steps – between now and 30-Jun-24 – will be to place the proposed new UK regulations before the World Trade Organisation (WTO). To quote MHRA’s 21-Oct-22 letter:
“Under the WTO Technical Barriers to Trade (TBT) agreement, the MHRA is required to notify the WTO and the draft regulations will be published by the WTO for a period of at least 60 days for comment prior to the regulations being laid within Parliament. This will provide an opportunity to all our key stakeholders to review and comment on the draft legislation before it comes into force.” Of course, BHTA will monitor closely MHRA’s progress toward this publication, and will keep members informed.”
On the GOV.uk website, MHRA have published an online announcement – Implementation of the Future Regulation – which, it seems, they will use as an online repository for updates on the progress of the new UK medical device regulations. In the meantime, BHTA know significant challenges remain. When DHSC/MHRA respond to our questions on these challenges, we will publish their answers on this page.
2. Will industry/trade associations get a chance to help formulate guidance on the new regulations?
Previous updates
08-Aug-22:
Yes – MHRA has indicated that it will re-constitute the “Focus Groups” it envisioned/created earlier in 2022 in order to provide industry/trade associations with the opportunity to help shape the guidance for the new regime. MHRA’s stated timeline for the “kick-off” of these Focus Groups is c. Oct-22. Given the slippage of nearly all previous dates connected to the Consultation/new regime, however, this timeline should be treated with caution. Moreover, MHRA is very clear that Focus Groups will only begin after the publication of the draft guidance outlined above, a key dependency that could cause delay. BHTA will participate in these Focus Groups, and we will share further details as they become available.
05-Oct-22:
The release of the regulations and guidance have been delayed – they are now unlikely to appear until sometime after Nov-22 (please see item 4 below for additional detail) – and thus it is unclear how/when MHRA might re-constitute planned Focus Groups. BHTA and others continue to push for TA and industry inclusion in any Focus Groups, whenever/however they might appear.
31-Oct-22:
It remains unclear how/when MHRA might re-constitute planned Focus Groups. BHTA and others continue to push for TA and industry inclusion in any Focus Groups, whenever/however they might appear; judging by the next steps outlined in MHRA’s 21-Oct-22 letter, it seems unlikely the Focus Groups will re-appear before late 2023. When DHSC/MHRA provide more information, we will publish it on this page.
3. Do the transitional arrangements outlined in Section 15 of MHRA’s consultation response (please see BHTA’s summary of the consultation response for full detail) include Class I medical devices, which are self-certified?
08-Aug-22:
Yes – MHRA confirmed that all classes of medical devices are covered under the transitional arrangements. Since Class I certificates do not have an expiry date, it is likely that the end date for acceptance of existing Class I device CE certification under the new UK regime will be the outer boundary defined in Section 15, i.e. five years after the new regulations take effect for devices certified under EU MDR (c. 01-Jul-28) or three years after the new regulations take effect for devices certified under EU MDD (c. 01-Jul-26). BHTA has sought further clarification on this issue and will share more information when it is forthcoming. (Back to top)
4. Will MHRA formalise the transitional arrangements outlined in Section 15 of their consultation response?
Previous updates
08-Aug-22:
Probably – MHRA has indicated that they are working to produce formal, written codification of the transitional arrangements. BHTA and other trade associations have pushed for this in order to provide aid and comfort to companies whose legal teams have pointed out that – helpful as the statements on transitional arrangements may be – the new regulatory regime is still scheduled to come into force on 01-Jul-23, and the extant statements in MHRA’s consultation response have insignificant standing in law. BHTA will share more information when it is forthcoming.
05-Oct-22:
Increasingly, companies are asking two questions:
Because the transitional arrangements announced in Section 15 of MHRA’s response to their own Consultation have not yet been set down in law, is the UKCA Mark still required as of 01-Jul-23?
Our understanding is: in practice, “no,” according to MHRA’s assurances; by the letter of the laws/regulations currently applicable in the UK, it would be hard to argue that the answer can be other than “yes.” Clearly this is unworkable, as BHTA and other trade associations have highlighted, increasingly forcefully, to MHRA.
Is it clear when the transitional arrangements announced in Section 15 of MHRA’s response to their own Consultation might be set down in law?
Early-Sep-22 indications from MHRA were that they were drafting two Statutory Instruments (SIs), with a plan to publish them “sometime in October 2022”:
It is likely that any guidance on the new regulations (the 2nd, “general” SI) can come only after a six-month cooling-off/public-response period, the “clock” for which begins when the SI is laid. Given all of extraordinary events/changes in Sep-22, it seems likely that MHRA’s plan to publish these SIs “sometime in October 2022” will slip into November 2022.
31-Oct-22:
It seems clear MHRA intend to bring forward two aspects of the new medical device regulations ahead of the wider, future regulatory regime – the Section 15 Transitional Arrangements and Post-Market Surveillance. To quote MHRA’s 21-Oct-22 letter:
“We continue to work on the development of the future regulations and are now taking the next steps to implement the transitional arrangements and post market surveillance requirements, as outlined in the Government response. For clarity, the timelines for the transitional arrangements will commence from when the new regulations come into force (i.e., July 2024). The MHRA aims to lay legislation within Spring 2023 to bring into force not only the transitional arrangements but also some post-market surveillance requirements.”
In the context of the new 01-Jul-24 implementation date, for the Section 15 Transitional Arrangements, BHTA understands this to mean:
For Post-Market Surveillance, BHTA understands this to mean:
When DHSC/MHRA provide more information, we will publish it on this page.
5. Will MHRA take a pragmatic view regarding audit completion by overstretched UK Conformity Assessment Bodies?
Previous updates
08-Aug-22:
Probably – the concern is that, for instance, some companies are caught in a situation where their current certificate is expiring prior to their UK CAB being able to re-audit their product(s) and issue a new certificate. Companies are worried that, through no fault of their own, they will be pulled up on this “technicality” when they have made all good-faith efforts to remain in compliance, and face circumstances beyond their control with regard to UK CAB capacity. BHTA will share more information when it is forthcoming.
05-Oct-22:
BHTA, other TAs, and individual companies continue to raise this problem with MHRA. We are also highlighting the fact that this affects not only UK CABs, but EU Notified Bodies (EU NBs), with knock-on effects for UK companies (and UK Responsible Persons, or UKRPs) doing everything in their power to update soon-to-expire CE certificates – and thus remain in compliance under MHRA’s transitional arrangements – but facing backlogs at UK CABs/EU NBs. This is especially vexing in situations where certificates that were issued under EU MDD are in the process of being converted to EU MDR, which involves more time and administration for UK CABs/EU NBs. Finally, we have highlighted that – even for existing customers of UK CABs/EU NBs – waiting times for audits/re-certification (especially for devices moving from one Class to another) average (anecdotally) between 9-12 months . . . to say nothing of companies seeking to be new customers of UK CABs/EU NBs (who are, by and large, being turned away full-stop due to lack of capacity).
31-Oct-22:
To quote MHRA’s 21-Oct-22 letter:
“We acknowledge concerns raised relating to capacity across the Approved Body system. There are currently four designated UKABs, with more in the pipeline. We are working proactively with six organisations who have applied to become UKABs, and several more who have expressed an interest in being designated, to enable them to achieve designation as swiftly as possible. We are taking a pragmatic, flexible approach where it is safe and proportionate to do so, whilst ensuring UK requirements are met. The extension of the standstill period will give more time for this work to progress. The UK remaining an attractive place to develop and market medical devices is vital for UK patients and we are committed to delivering this through the future regime.”
Although this general sentiment is welcome, we have asked for specifics as to how DHSC/MHRA will factor in issues of capacity at UK CABs and EU NBs. We have relayed that current conversations with BHTA members indicate that existing customers of UK CABs/EU NBs now face waiting times of 12-18 months for completion of audit and compliance tasks (from simple recertification to more complex MDD-to-MDR conversion), and new customers are being turned away entirely. Having removed a possible July 2023 cliff-edge, we have underscored to DHSC/MHRA that we would hate to see one re-emerge in July 2024.
MHRA has offered no further clarity on this issue as yet; BHTA and other TAs continue to press it. When DHSC/MHRA respond to our questions, we will publish their answers on this page.
6. How, exactly, is “Distributor” to be defined under the new regulations – does the definition encompass anyone who hands a device to an end-user?
Previous updates
08-Aug-22:
Unclear – BHTA is concerned that the definition of “Distributor” should be considered carefully. If it includes end-sellers/those who hand a device to the end user, these requirements will apply to hospitals, care homes, dispensing contractors and retailers (including those who may sell only one or two medical devices, such as sticking plasters). They may not have the capacity or understanding to comply and we question how this will be policed effectively. It may deter retailers from selling these items to the potential detriment of consumers. It will almost certainly increase costs for the health and care service. Guidance will be needed on what constitutes an “appropriate” Quality Management System, in proportion to the risk of the device, to ensure this does not act as a deterrent for placing low-cost, low-risk items on the market. Micro businesses, in particular, will appreciate more guidance regarding risk management for medical devices and facilitating this may have more effect than insistence, for example, on a formal standard being followed for quality management. If a requirement to keep records is introduced, we suggest the timescale for retention should be in line with existing requirements for retention of financial information by businesses, i.e. six years.
31-Oct-22:
MHRA has offered no further clarity on this issue as yet; BHTA and other TAs continue to press it. When DHSC/MHRA respond to our questions, we will publish their answers on this page.
7. How will the re-set of the implementation of new UK medical device regulations to 01-Jul-24 interact with timetables already in flight for EU MDD/EU MDR?
31-Oct-22:
BHTA has asked DHSC/MHRA for detail on interactions with EU MDD/EU MDR – i.e. the currently-applicable regulations that deliver the checks, proofs, and labelling for Declarations of Conformity (Class 1 devices) and CE Certificates (Class 2-&-above devices) that DHSC/MHRA will accept until 01-Jul-24 (e.g. 26-May-24 = Certificates issued under MDD become void, and this is the last date for placing medical devices on the market unless they meet MDR requirements; 26-May-25 = Last date for end-users (e.g. hospitals) to put into service products certified under MDD).
MHRA has offered no further clarity on this issue as yet; BHTA and other TAs continue to press it. When DHSC/MHRA respond to our questions, we will publish their answers on this page.
8. How might Exceptional Use Authorisations (EUAs) be used as a temporary solution in this time of regulatory flux?
31-Oct-22:
BHTA has learned from several members that – in conversations with DHSC/MHRA, but not, as yet, in writing – DHSC/MHRA have held out Exceptional Use Authorisations (EUAs) as “temporary solutions” in this time of regulatory flux. We have asked DHSC/MHRA for written clarification on this issue; specifically, we have asked will EUAs:
MHRA has offered no further clarity on this issue as yet; BHTA and other TAs continue to press it. When DHSC/MHRA respond to our questions, we will publish their answers on this page.
BHTA’s comments regarding the MHRA’s response to Consultation on the Future of Medical Device Regulation in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published its response to its consultation on the future of medical device regulation in the UK (26-Jun-22 press release and the full MHRA response Consultation on the Future Regulation of Medical Devices in the United Kingdom).
The new regulatory regime is still scheduled to come into force on 01-Jul-23, but – BHTA is pleased to note – the government has acknowledged serious concerns raised by BHTA, other trade associations and industry, with regard to continuity of supply, shortage of conformity assessment bodies, hard-pressed MHRA resource, and the need for industry input into guidance on how the regime will operate… click to continue to the full BHTA response here