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 is delighted to formally announce our successful designation under the existing 3 Medical Device Directives (MDD/AIMD and IVDD) in the Netherlands. These designations represent a significant milestone in our Medical Device Regulatory activity and more than two years of work in achieving this milestone. This firmly anchors BSI presence as a Medical Device notified body irrespective of the BREXIT outcome.
It is important to note that BSI’s strong preference remains to develop the new NL NB in parallel to our successful and growing UK Notified Body. Also, to ensure both NB’s progress towards successfully achieving MDR and IVDR designation, working closely with our very supportive competent authorities the MHRA (UK) and IGJ (NL).
To ensure market access specifically for either option two or three (see above), we started the process of applying for full scope Notified Body status in the Netherlands under both existing and forthcoming regulations in September 2016. Current status:
- RVA accreditation for manufacturing facility certification (ISO 13485) completed April 2018
- Medical Device Directive designation (MDD, AIMD, and IVDD) received in November 2018