MDR and IVDR Critical Update

BSI has submitted designation applications for the Medical Devices Regulation (Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746)  to both the UK and The Netherlands Competent Authorities. 26 November 2017 was the first day that Notified Bodies were allowed to apply for designation under the MDR and IVDR, BSI were among the first wave of Notified Bodies to submit for both Regulations. The next step is for the Designating Authority, MHRA in the UK and IGJ in The Netherlands, to review our application and write a preliminary report to be sent to the Commission so that they can schedule Joint Assessment audits of BSI.

BSI is proud to work towards designation for these critical Regulations and will continue to strive for excellence in our Notified Body activities over the transition period. We will ensure that you are kept up to date with the progression going forward.