UK regulation of medical devices from 1 January 2021

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern Ireland following the expiry of the Brexit transition period under the EU-UK Withdrawal Agreement on 31 December 2020.

The Guidance is of relevance to all medical device companies operating or selling devices in the UK. It retains many of the elements of the MHRA's previous "no-deal" Brexit guidance but differs in certain respects, including setting a clear timeline for a new UK medical device regulation framework from July 2023.

Read our insights here.