Here’s how the UK will regulate medical devices after Brexit

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 activ…
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