MDCG 2023-3 Q&A in Vigilance Terms and Concepts in the MDR and IVDR Updated

MDCG has published MDCG 2023-3 Rev.2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The guidance provides advice concerning vigilance obligations related to medical devices and in vitro diagnostic devices governed by the MDR and IVDR. The fact that the guidance applies to medical devices falling within both the Medical Devices Regulation (MDR) and the IVDR has been underlined along with related examples. Among the helpful updates in Revision 2 are clarifications to the scope of the terms “incident” and “serious incident”, the circumstances in which each term should be considered to apply, and the criteria to be applied for reporting serious incidents arising in relation to devices falling within the scope of the Regulations. Among the practical additions are guidance concerning when “manufacturer awareness” is considered to have occurred and what is to be considered “use errors”.