First IVDR Annex IX Chapter II Class D Certificate issued

Date: 09 February 2023

BSI IVDR Notified Body issued its first IVDR Annex IX Chapter II Class D certificate on 11 January 2023. The manufacturer was Roche Molecular Systems and the certified device is used to screen blood donations for HEV infection.

Alex Laan, Head of BSI IVD Notified Body, says: "Understanding the challenging regulatory circumstances for conformity assessment of Class D IVDs in Europe, without the availability of European Reference Labs, it gives us pride to see that our IVD Team was able to come to a positive conclusion to support the first IVDR certification for the HEV assay of Roche. This is also going to be a very positive signal towards blood transfusion centres that use the device for screening blood donations on HEV infections, supporting the EU healthcare system."

Liz Harrison, BSI Global Head of IVD, says: "This is a huge milestone that we have been working towards since our BSI Netherlands IVDR designation in December 2019. I would like to thank our team of technical reviewers and QMS assessors for their diligence in ensuring high risk devices undergo rigorous assessment. I also want to thank our customers for working with us over the challenging IVDR transition. In the absence of designated European Reference Laboratories, BSI has implemented a risk-based approach to the certification of Class D devices and we are pleased to issue our first certificate in 2023.”