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