The MHRA announced today that CE Certificates granted further extension in Europe, will be recognized in Great Britain: HERE
The MDR transition extension automatically applied in Northern Ireland on the date of its implementation, since CE Marking is mandatory in Northern Ireland. However, Great Britain (England, Scotland, Wales), has its own autonomous regulatory system separate from Europe and CE Marking.
Per today’s announcement, they have decided that CE Marking certificates valid under the conditions of the MDR’s transition period extension, “will also be recognised as valid for placing CE marked devices on the GB market.”
This means that devices which:
- Expired prior to 20 March 2023, but met the conditions outlined in Regulation 2023/607 (i.e., the regulation extending the transition period), or
- Will expire 20 March 2023 or after, but meet the conditions outlined in Regulation 2023/607
Will be considered valid throughout the United Kingdom – Northern Ireland and Great Britain.
The MHRA has not yet updated its guidance to reflect this change. We expect more details to be released in the near future.
For more information on the extension of the MDR transition period, please read: MDR Extension Published, Enters into Force Today