Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU -- MEDICA - World Forum for Medicine

17.11.2020

Obelis S.A. Obelis European Authorized Representative Center

Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU

On 1st September, 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published its latest Guidance outlining the requirements for placing medical devices on the markets of Great Britain (England, Scotland and Wales), Northern Ireland (NIR) and the European Union (EU) respectively.

The guidance provides some insight into how certain aspects of the UK’s system will operate, including:
- Getting devices certified;
- Conformity marking of devices;
- Registering devices with the MHRA.

Exhibitor Data Sheet