This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU)
2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations.
The document is written for competent authorities, economic operators and other relevant parties.
Some of the definitions presented in this document are reintroduced from the Guidelines on a Medical Devices Vigilance System1 with, where relevant, modifications for alignment with the MDR and IVDR.
Unless quoted directly from the legal text or otherwise specified, the term ‘devices’ will be
understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices.
Furthermore, references to ‘the Regulations’ should be understood to cover both the MDR and the IVDR.
This document is non-exhaustive and should be read in conjunction with the Regulations, relevant standards, and MDCG guidance documents…
