On Thursday, the MHRA launched its public consultation on the future regulation of medical devices in the UK. The publication of the consultation will be welcomed by stakeholders. The consultation (first announced in the MHRA’s Delivery Plan 2021-2023) is open until the 25th of November, with a response due to be published next April. The timeline is definitely tight for stakeholders and we expect a number of comments.
The MHRA reaffirmed the requirement to migrate to UKCA Marks in place of CE Marks by the 1st of July 2023. This leaves manufacturers 22 months to have devices recertified to meet a set of standards which have not yet been finalised. Combine this with the grand total of three UK Approved Bodies (as of July 2021) to recertify every medical device, it looks like a bottleneck looms in the near future.
The good news is that many of the proposed changes will ensure that the UK is harmonised with the international frameworks including the EU MDR and EU IVDR.
In other areas, it appears as though the MHRA intends to clarify issues such as whether the definition of “placing on the market” should encompass deploying medical software on a website or deployment via App Stores. We also recommend that readers take a look at Section 73 in Chapter 14 of the consultation regarding a new pathway to market for “Innovative MedTech”.
The MHRA’s Delivery Plan 2021-2023 stated that the consultation would be published by Q2 of the 2021/22 fiscal year (April-to-April). We were delighted to see the consultation published with two weeks to spare.
Our life sciences regulation experts explain the key changes proposed in an article here, and if you have time, you can also watch a recording of their quick reaction webinar on our On The Pulse podcast and video page.