BSI Netherlands Successfully Achieves Designation as a Medical Device Notified Body

E-news: 13 November 2018

Netherlands FlagBSI is delighted to formally announce our successful designation under the existing 3 Medical Device Directives (MDD/AIMDD 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's presence as a Medical Devices 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  VWS(NL).