UK - MHRA Guidance on extended transition periods

The MHRA has published a guidance document detailing their position concerning the adapted MDR transition periods resulting from Regulation (EU) 2023/607. The MHRA proposes that "lecacy devices" that are CE-marked according to the new rules can be placed on the British market maximum until 30 June 2028 (medical devices and active implants) or 30 June 2030 (IVD), respectively. In addition, they make a template available to manufacturers that can be used to confirm that the requirements for the extended transition in accordance with Article 120 MDR are met.

For devices that are CE-marked in accordance with the MDR or IVDR, the MHRA announces 30 June 2030 as the end of the recognition in Great Britain. All announcements are subject to parliamentary approval for an update of the respective law. Currently recognition of CE-marked devices ends on 30 June 2023.