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.
We are making significant progress regarding our applications for completing our business out of our already active Amsterdam office. 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.
IGJ has also completed our initial audit to the three EU Medical Device Directives, and we are working through the process of designation, with a target of designation in July/August 2018. Our application for the MDR and IVDR is currently in the first wave of applications for these new Regulations.
BSI continues to work closely with all relevant UK government departments including the Medicines & Healthcare products Regulatory Authority to ensure they understand the implications not only for UK Notified Bodies, but more importantly for our clients and patients who use these products.