This document is intended for sponsors of clinical investigations of devices conducted within
the scope of the Regulation (EU) 2017/745 (MDR). This document may be supplemented in
due course with further questions and answers.
Throughout this document the term ꞌdeviceꞌ is used with the same meaning as in the MDR,
i.e., for the purpose of the MDR, medical devices, accessories for medical devices and
products listed in Annex XVI of the MDR and to which the MDR applies, shall hereinafter be
referred to as ꞌdevicesꞌ1
.
Further, the term “clinical investigation” is used throughout with same meaning as in the MDR
Article 2(45), i.e. “any systematic investigation involving one or more human subjects,
undertaken to assess the safety or performance of a device”…
