On October 21st, 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) distributed a letter to the medical device and IVD industry to explain its intention to extend the current standstill period by twelve months from July 2023 to July 2024. This extension implies that for an additional period of 12 months, valid CE marks would continue to be accepted in Great Britain (GB) and it would also imply that the start date for mandatory use of the UK Conformity Assessed (UKCA) marking in Great Britain UK Conformity Assessed has been delayed until July 1st, 2024.
The letter further details that this additional year allows the regulator the time needed to fully develop the legislation and ensure support system readiness. It is thus their intent to introduce the new UK medical device regulations in July 2024. The specific details of the new UK medical device regulations have yet to be published following the public consultation which was held in 2021. The new UK medical device regulation will be closely aligned the EU Medical Device and IVD Regulations.
The MHRA’s open letter states that they are now taking the next steps to implement the transitional arrangements and post market surveillance requirements, as outlined in the Government response to the public consultation. The timelines for the transitional arrangements will commence from when the new regulations come into force, i.e., July 2024.
It is important to note that this extension is not yet confirmed by law so further updates are expected to the MHRA website and we expect new legislation to be issued in the near future.
Northern Ireland is not affected by this, as it will remain under CE-marking jurisdiction.
What does this mean to you?
This letter is welcome news to all manufacturers relying on their CE mark to access the Great-Britain market as it allows an additional year to obtain the UKCA marking.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.