New MDCG guidance – questions and answers on vigilance terms and concepts according to MDR available
6 March 2023
On February 14, 2023, the MDCG 2023-3 document “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices” endorsed by the Medical Device Coordination Group (MDCG) was published.
MDCG 2023-3 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 MDCG document is written for competent authorities, economic operators, and other relevant parties.
Some of the definitions presented in the MDCG document are reintroduced from the Guidelines on a Medical Devices Vigilance System (Guidelines on a Medical Device Vigilance System, MEDDEV 2/12-1 rev. 8, Januar 2013) 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 MDCG document is non-exhaustive and should be read in conjunction with the MDR, relevant standards and MDCG guidance documents.
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 MDCG 2023-3. The MDCG document is intended to be updated to include the IVDR.
