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.
The term ‘devices’ will be understood to include medical devices, accessories for medical devices and products listed in Annex XVI to the MDR.
The document is non-exhaustive and should be read in conjunction with the MDR, relevant standards2 and MDCG guidance documents3
Terms and concepts that are outlined in the corresponding articles of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this document.