On 25 November 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) consultation on proposed changes to the regulation of medical devices in the UK closed. The government response was published on 26 June 2022. The government confirmed its intention to proceed with the large majority of the proposals.

This Practice Note serves as a reference guide to compare key provisions of the current UK regime for medical devices; the EU regime as governed by the Medical Devices Regulation (MDR), Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Device Regulation (IVDR), Regulation (EU) 2017/746; and the proposed UK changes, which are due to apply from July 2024 with transitional provisions.

It should be noted that the MHRA announced that it will postpone the new medical device regulations from coming into force by one year from spring 2023 to spring 2024, with transitional provisions also being extended accordingly by one year. The extension was announced before being confirmed by law and there may be a delay before the MHRA updates its website and guidance, so be