As the United Kingdom is preparing to leave the European Union (EU), it has issued an outline of how medical devices will be regulated in 2021 after Brexit.
The first thing to know is that starting from January 1, 2021 – the responsibilities for the UK medical devices market that are currently governed by the EU will be taken over by the Medicines and Healthcare products Regulatory Agency (MHRA).
Changes to these rules 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, but there is a grace period, including:
- 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 will 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. However, if the manufacturer is not based in the UK but wishes to put a medical device on the UK market – it will be required to establish a local “responsible person.” Said individual or company 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.
Entities based in Northern Ireland who register devices with the MHRA for the purposes of the local market can have their device freely flow between countries and will not need further registration in the UK.
Additionally, the UK will also implement a new product marking called the UKCA (UK Conformity Assessed) for certain goods from Jan. 1, 2021, medical devices being among them. UKCA will not be recognized in the EU, EEA or Northern Ireland markets.
After July 1, 2023, placing a device in the UK 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 designations under the MDD, IVDD or AIMDD will have designations rolled over automatically.