Updated UK Regulation for medical devices
Read this update about a new UK medical device Regulation and about different rules for Northern Ireland.
Northern Ireland Protocol and CE marking
Northern Ireland is considered to be a special case, when it comes to conformity legislation, since the UKCA marking (valid in Great Britain (GB)) is not recognized in Northern Ireland (NI). As of January 1, 2021, the NI product certification is covered by the Northern Ireland Protocol.
UKCA: the new marking within the UK market
To gain an understanding of the UKCA conformity procedures, it is important to receive an in-depth overview of the basic amendments. Let us briefly outline the post-Brexit effects on the UK market landscape, specifically with regard to product certification for placing products on the GB (Great Britain) market.