Extension of CE Mark recognition for placing medical devices on the Great Britain (GB) market
Legislation has now been published to extend the acceptance of the CE mark for placing medical devices on the GB market beyond Jun 2023 (reference Medical Devices (Amendment) (Great Britain) Regulations 2023 No 627).
The table below summarises requirements and dates relating to transitional measures for placing CE marked medical devices on the GB Market.
* Declaration of conformity to MDD requirements must have been made before 26 May 2021.
Manufacturers will not be able to rely on expired certificates if placing medical devices on the GB market under these transitional measures, (unless such certificates have been otherwise deemed valid by the EU).
Guidance document and a very useful timeline infographic are available:
in vitro diagnostic medical devices on the Great Britain (GB) market
The table below summarises requirements and dates relating to transitional measures for placing CE marked in vitro diagnostic medical devices on the GB Market.
*IVDD EC Certificates become void on 27 May 2025.
** Declaration of conformity to IVDD requirements must have been made before 26 May 2022.
Manufacturers will not be able to rely on expired certificates if placing medical devices on the GB market under these transitional measures, (unless such certificates have been otherwise deemed valid by the EU).
Guidance document and a very useful timeline infographic are available:
