The UK no longer recognizes the CE mark! MHRA authentication will be enabled
Recently, the UK government has officially announced on its page: The UK has left the EU, and the transition period after Brexit comes to an end this year (Feb.1-Dec.31, 2020). From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
In other words, CE certification will no longer be used in the UK, after which manufacturers must be labeled with the UKCA (UK Compliance Assessment Mark). Turn its own independent MHRA certification on.
Summary of key requirements for placing a device on the Great Britain market
From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:
- CE marking will continue to be used and recognized until 30 June 2023.
- Certificates issued by European Economic Area (EEA)-based Notified Bodies 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.
From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices. 8 months for other Class IIb and all Class IIa devices. 12 months for Class I devices.
What is the UKCA mark?
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.
How will UK Conformity Assessment Bodies work?
From 1 January 2021, the MHRA will be able to designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark.
Existing UK Notified Bodies with designations under the MDD, IVDD, or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
UK Approved Bodies will only be able to conduct conformity assessments, in relation to the UKCA mark, for medical devices, active implantable medical devices, and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (in the form in which they exist on 1 January 2021).