MHRA Highlights Intention to Extend UKCA Date by 12 Months
Member communication issued on 21st October 2022
As the ongoing regulatory situation persists, we have been working hard on your behalf to help reduce uncertainty and clarify the future roadmap.
Today we received a letter from MHRA, which states the regulator's intention to set out UK legislation that will extend the standstill period during which CE marking is accepted in the UK for one more year to July 2024. According to MHRA, the planned transitions will then start from when the new regulations come into force, alongside new post-market surveillance requirements.
It must be stressed that this is not in legislation yet. However, this is an important step by MHRA, and provides a degree of reassurance that we will now progress in-line with the government proposals published in June.
Though of course welcome, and we are glad to hear that our calls are being listened to, major concerns do still remain. One cliff edge may be averted, but progress over the coming months must be rapid and decisive if we are to avert a similar cliff edge scenario one year from now. There is also limited Approved Body capacity to service the sector, and this must be addressed as a matter of urgency.
ABHI continues to advocate for a clearer roadmap for the future requirements for legislation and supporting infrastructure, framed around the '3Rs' that I previously highlighted. The Life Sciences Vision rightly calls out the need to ensure the development of a best in class regulatory regime, and it is absolutely critical that we meet this ambition in order to position the UK as an attractive market to develop, manufacture and supply health technologies.
As ever, we will keep you updated on progress and I would like to thank members for their continued support, particularly around this critical issue which we are working to unlock. Given the Prime Minister's resignation this week, we will of course brief any new ministers of our concerns as a matter of priority following the leadership election.
Steve Lee, Director, Diagnostics, ABHI
Update: 25th October 2022
MHRA have now published an update online about the implementation of the future regulations. The update can be found here.