Early this year United Kingdom (UK) has left the European Union, and the Brexit transition period will be over this year (until 31 December 2020). Due to pandemic, the MDR and IVDR’s full application in EU Member States are postponed to 26 May 2021 and 26 May 2022 respectively. These regulations will not be EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain (England, Wales and Scotland). Different rules will apply to Northern Ireland.
The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on 1 September 2020, which related with how medical devices will be regulated in the Great Britain after Brexit transition period (from 1 January 2021).
Summary of key requirements are as following:
- CE marking will continue to be used and recognized in Great Britain until 30 June 2023
- Certificates issued by European Economic Area (EEA)-based Notified Bodies (NB) will continue to be valid for the Great Britain market until 30 June 2023
- A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021 (after the Brexit transition period)
- From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed in the UK market will need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). There will be a grace period for registering:
- 4 months (until 30 April 2021) for Class IIIs and Class IIb implantable, and all active implantable medical devices
- 8 months (until 31 August 2021) for other Class IIb and all Class IIa devices
- 12 months (until 31 December 2021) for Class I devices
- The above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.
- A manufacturer based outside the UK and wish to place a device on the UK market, will need to establish a UK Responsible Person who will take full responsibility for the product in the UK.
- A medical device which has been manufactured in Northern Ireland and registered with the MHRA for the purposes of marketing in Northern Ireland, can freely flow between Northern Ireland and Great Britain and will not need to undergo any further registration in Great Britain.
- The UKCA (UK Conformity Assessed) mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market after the transition period.
- The UKCA mark will not be recognized in the EU, EEA or Northern Ireland markets, and products currently requiring a CE marking will still need a CE mark for sale in these markets.
- Manufacturers will be able to use the UKCA mark from 1 January 2021.
- Devices that have been CE marked by Northern Ireland traders will continue to be accepted on the Great Britain market beyond 30 June 2023.
More detailed information can be consulted directly from the Guidance Document.