BDIA Update
Are delays now inevitable?
Edmund Proffitt looks at the delays in MHRA activity which are impacting on the introduction of the new UKCA regulations for medical devices.
The MHRA’s consultation on the new ‘UKCA’ medical devices regime ended in November and we still await the publication of the agency’s consultation response. Deadlines for this publication have come and gone, along with a lot of MHRA staff, and despite an expectation for publication at the end of March, it could now be as late as May before anything is seen. When eventually published the MHRA has confirmed that its consultation response will contain some of the decisions it has taken regarding future policies. There had been some speculation that the response would
Edmund Proffitt is the chief executive at the BDIA.
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merely summarise the comments received by the MHRA, but we are hopeful that the response will start to provide some insights to assist members in their planning and preparation, particularly in relation to transitional arrangements and routes to market. This is particularly important given the continued delays in publication and the ever-looming implementation date of the new UKCA regulations of July 1, 2023. However, this date is now has to be very much in doubt. More delays Compounding this situation, though the MHRA has hosted the first of its industry and trade association focus group meetings discussing the new guidance that will sit alongside the new UKCA requirements, the next 13 follow up meetings scheduled to take place throughout the year until December have now been delayed a month and
are due to commence in early May. This latest delay in proceedings is due to the pre-election period for government communications, known as ‘purdah’. The purpose of the initial meeting was to review the schedule of meetings and subjects to be reviewed. At the request of industry, the MHRA did change its initial proposed schedule in recognition of the very limited time available and the need to address transitional arrangements as a matter of urgency. The further delayed schedule will now inevitably delay things even more and impact on the time that industry has to discuss guidelines that are being written on legislation that we have not yet even seen, which, in itself, is an unusual scenario. When will we see the regulations? Meanwhile, the MHRA has offered some more information on the timing of the regulation itself. We understand that Issue 1 2022
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