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…
