Guidance about how medical devices will be regulated in the UK in a no deal scenario

Dear colleague

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However, the government must prepare for every eventuality, including a no deal scenario.

Today we have published guidance that sets out how medical devices will be regulated in the UK in a no deal scenario. References in this guidance to events happening “after” or “from” 29 March 2019 are to be read as references to events which happen at or after 11pm on the 29 March 2019.

If there is no deal with the EU concerning the terms of the UK’s withdrawal from the EU, the UK’s current participation in the European regulatory network for medical devices would end, and the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the responsibilities for the UK market currently undertaken through the EU system.

This guidance provides further detail on how the UK system would operate, including for:

·       getting your device certified

·       CE marking your device

·       registering your device with the MHRA

 

These proposals are still subject to parliamentary approval of the changes to the relevant statutory instruments that are required to bring these proposals into law.

All current information from MHRA relating to a possible no deal scenario can be found on our website. The Department of Health and Social Care has a similar page with sector-wide guidance, including contingency plans for a no-deal Brexit.

 

If you have any queries, please email engagement@mhra.gov.uk.

Published on: 27 February 2019
Last Updated On: 15 March 2019