[Emergo, UL] EU Releases Guidance on IVD Performance Studies, Finally

The European Commission (EC) released 54 Questions & Answers on In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) Performance Studies, MDCG 2025-5.  This follows the analogous guidance for the Medical Devices Regulation (EU) 2017/745 MDR) clinical investigations from 2021 (MDCG 2021-6, revised 2023).

 

This has been a long-awaited guidance document. In the interim, many competent authorities augmented their position with their own guidance on IVDR Performance Studies. All 54 Questions are delineated in the table of contents.

 

The Introduction section reminds entities that ethics review requirements are not imposed by the IVDR: “It is thus necessary to check national requirements in relation to submission to the ethics committee and where possible make sure that the ethics committees and competent authorities have access to the same versions of updated documents.”

 

In addition, while central institution review boards have been a topic of interest in the U.S., based on the 27 EU member states and signatories, the concept of a more centralized Ethics Review Board or Ethics Committee does not appear to yet exist.

 

 

EU Releases Guidance on IVD Performance Studies, Finally | Emergo by UL

EU Releases Guidance on IVD Performance Studies, Finally