According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body. In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL). This document provides indications for how to apply the IVDR provisions related to expert panels and EURLs before the IVDR application date, i.e. 26 May 2022, as well as around the time when the first EURL designations become applicable for the purpose of EURL tasks (1 October 2024 according to Commission Implementing Regulation (EU) 2023/2713).
MDCG 2021-4 rev.1 - Application of transitional provisions for certification of class D in vitro diagnostic medical devices unde
MDCG 2021-4 rev.1 - Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Regulation (EU) 2017/746 - September 2024
health.ec.europa.eu
