BSI announcement (Netherlands): successful designation under IVDD, MDD and AIMDD
Posted on 06.12.2018
On 13 November 2018, BSI officially announced that they achieved successful designation in the Netherlands under the existing three medical devices Directives – links to the publications in the official Gazette in the Netherlands are available here MDD/AIMDD and here IVDD. BSI is now also notified under the three Directives – for more information please consult the European Commission NANDO database.
BSI is the first UK Notified Body (NB) to have successfully achieved designation (as BSI Netherlands) in an EU and non-UK country following the decision by the UK to leave the EU. They remain designated (as BSI UK) under the three medical devices Directives until the UK leaves the EU and in the absence of any agreement which recognises UK NBs. Their designation under IVDR and MDR both in the UK and the Netherlands are still ongoing.
For more information, please contact Merlin Rietschel.