Image from Jonathan Chng on Unsplash
The United Kingdom issued an outline of how it intends to regulate medical devices beginning in 2021 after Brexit.
From Jan. 1, 2021, the responsibilities for the UK medical devices market that are currently governed by the European Union (EU) will be taken over by the Medicines and Healthcare products Regulatory Agency (MHRA), the guidance said.
Changes to how medical devices reach the market in the UK will be implemented over time, although CE Mark approval will continue to be used and recognized until June 30, 2023, as will certificates issued by European Economic Area (EEA)-based notified bodies.
After Jan. 1, 2021, all medical devices and in vitro diagnostic medical devices placed on the UK market must be registered with the MHRA, although a grace period for registering includes:
- Four 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
The 12-month grace period does not apply to manufacturers of Class I devices and in vitro diagnostics that are currently required to register with the MHRA.
MHRA will only register devices where manufacturers have a registered place of business in the UK. If the manufacturer is based outside the UK and wishes to put a medical device on the UK market will be required to establish a UK “responsible person” who will take responsibility for the product in the UK. Most notably, the person will provide MHRA will all information and documentation necessary for demonstrating the conformity of a device, forward requests from the MHRA to manufacturers and cooperate with the MHRA on any preventive or corrective action.
Northern Ireland-based manufacturers who register devices with the MHRA for the purposes of Northern Ireland can have their device freely flow between countries and will not need further registration in the UK.
The UK will also implement a new product marking called the UKCA (UK Conformity Assessed) for certain goods from Jan. 1, 2021, including medical devices, that are placed on the market after the transition period. UKCA will not be recognized in the EU, EEA or Northern Ireland markets, so products that currently require CE Mark approval will still need such approval in these markets.
After July 1, 2023, placing a device on the Great Britain market will require meeting the guidelines of UKCA marking, although this will not apply to Northern Ireland traders. MHRA will be able to designate UK approved bodies to assess requirements for the purpose of the UKCA mark after Jan. 1, 2021, although existing UK notified bodies with designation sunder the MDD, IVDD or AIMDD will have designations rolled over automatically.
