This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). Establishing a
common understanding of these terms and concepts is necessary for an effective and
harmonised implementation of the vigilance requirements under the MDR.
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…
