An update on Brexit and BSI Medical Device Notified Body

4 May 2018

As you are aware Brexit is posing many questions and uncertainties in our sector so we would like to update you on the latest information we have regarding Brexit and your Medical Device Notified Body.

EU Commission data indicates that approaching half of all medical device products certified in the EU use UK Notified Bodies; BSI is Europe’s leading Notified Body for high-risk medical devices. We have a strong contingency plan in place to ensure that you, our global clients, can continue to use BSI as your European Notified Body but we also wanted to provide you with some wider information to support this substantial change.

BSI has now achieved Accreditation for ISO 13485 under the Dutch Accreditation Council (RVA); this is a major advancement in our preparations for Brexit contingency plans.

Brexit: Current status and timelines