BHTA – along with other trade associations and industry representatives – is meeting with MHRA officials regularly during the transition to the new regulatory regime to ensure your needs are raised and heard.
Following the MHRA’s response to its Consultation on the Future Regulation of Medical Devices in the United Kingdom, BHTA has created this new webpage to keep you abreast of regulatory developments as these come to light.
This page will provide you with the latest information and updates from the MHRA as it is received. This page will also be revised and updated on a regular basis, forming an FAQ on the new medical device regulatory regime.
BHTA member update – 8 August 2022
Updates from MHRA / Trade Association Liasion Meeting – 4th August 2022
Will MHRA provide guidance for “on-the-ground” operation of the new regulations under the new medical device regime?
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.
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Will industry/trade associations get a chance to help formulate guidance on the new regulations?
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 Moreover, MHRA is very clear that Focus Groups will only begin after the publication of the draft guidance outlined above, a key dependency that could cause delay.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.
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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?
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.
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Will MHRA formalise the transitional arrangements outlined in Section 15 of their consultation response?
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.
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Will MHRA take a pragmatic view regarding audit completion by overstretched UK Conformity Assessment Bodies?
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.
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How, exactly, is “Distributor” to be defined under the new regulations – does the definition encompass anyone who hands a device to an end-user?
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.
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BHTA member update – 27 June 2022
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