24th October 2022
In a move that is unlikely to have shocked those in the industry (but will nevertheless have generated a collective sigh of relief), the Medicines & Healthcare products Regulatory Agency (MHRA) confirmed on Friday, 21 October, that a twelve month extension has been applied to the current standstill period for the future Medical Devices regime in the UK – until July 2024.
With the regulations initially due to come into force in just eight months’ time (July 2023), the complete lack of evidence that a robust framework could be achieved in the available timescales (we’re yet to even see draft legislation) saw speculation that the initial implementation date would have to be reconsidered. It seems the MHRA have finally reached the same conclusion. In their letter announcing the extension the MHRA notes the importance of ensuring the future regime is “…robust and reflects the detail required to avoid disruption to supplies, support innovation and enable safe access to Medical Devices for UK patients.”
The letter confirms that work to develop the regulations is on-going with the next steps, namely to implement the transitional arrangements (which will commence when the new regulations come into force in July 2024) and post market surveillance requirements, intended to be dealt with in legislation laid in Spring 2023. The MHRA note “Bringing into force the new post-market surveillance requirements ahead of the wider future regulatory regime reflects the high priority assigned to patient safety in the future framework.”
The MHRA’s letter even acknowledges the concerns raised about the capacity of the UK Approved Body (UKAB) system, currently made up of just four designated approved conformity assessment organisations. Given the requirement for a UKAB to be involved in what can only be described as the mammoth task of replacing CE marks with UKCA marks to signify conformity with the as yet unknown UK regulations across all but the most basic of medical devices placed on the UK market, the news that the MHRA are “working proactively with six organisations who have applied to become UKABs, and several more who have expressed an interest in being designated…” is something of a relief.
The final paragraphs of the letter re-state the MHRA’s commitment to “prioritising and protecting patient safety”, signpost their latest Software and Artificial Intelligence as Medical Devices Change Programme Roadmap (which forms part of their overall framework reforms) and confirm guidance will be produced to support the interpretation of the future regulations.
With so little progress having been made to date, the initial deadline for implementation of the new regulations looming large and the current political turmoil, the MHRA have taken the only sensible option in a bid to “provide additional time to develop the legislation and support system readiness”. The only question that remains is – will another twelve months be enough? Watch this space.
If you have any queries or concerns, or if you are interested in receiving legal and practical advice in relation to any regulatory-related issues, please contact Walker Morris Regulatory specialist Claire Burrows.