[EU] MDCG 2025-5 - Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 (June 2025)

Introduction

This document is intended for sponsors of performance studies of in vitro diagnostic medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746 (IVDR). It also contains information of relevance to manufacturers providing IVDs for use in performance studies that may be sponsored by other actors, and sponsors of combined studies.

 

Throughout this document, the term ꞌin vitro diagnostic medical deviceꞌ (IVD) is used with the same meaning as in Article 2(2) of the IVDR, i.e., in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices. Note that the IVDR regulates in vitro diagnostic medical devices, and also applies to performance studies concerning such devices and accessories conducted in the union. The IVDR does not regulate clinical or laboratory methods describing, e.g., workflows or operating procedures of a device in the laboratory. Thus, the scope of performance studies is device performance.

 

 

MDCG 2025-5 - Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 (June 2025) - European Commission

MDCG 2025-5 - Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 201