UK: Post-Brexit medical device regulatory bill passed into law

ARQon
Jul 8, 2021
2 min read

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period. Starting 1 January 2021:

Medical devices and IVDs need to be registered with the MHRA before being placed on the Great Britain market. Grace period depends on the medical device risk classification.
Manufacturers established in the UK need to register with the MHRA. If they are not established in the UK, they will need to designate a UK Responsible Person.
The UKCA mark in replacement to the CE mark will come into effect from 1 January 2021 and this will run in parallel to the CE mark scheme for two years. Manufacturers are able to use the new UKCA mark from 1 January 2021. However, the MHRA will continue to recognise medical devices that have been approved for the EU market, and CE-marked, until 30 June 2023, including devices placed on the market under the EU MDR or EU IVDR. The UKCA mark will not be recognised in the EU; a CE mark will still be needed for those markets.
Devices that have been conformity assessed by a UK-notified body may not be placed on the EU market. Devices placed on the EU market before 1 January 2021 may remain on the EU market.
Great Britain manufacturers need to appoint an EU Authorised Representative and place products on the EU market, even if it has self-certified.
New devices placed on the Great Britain market will need to conform with UKCA marking requirements.
EU-notified body certificates will continue to be valid in Great Britain.