The MDCG guidance document MDCG 2023-3 has been updated. Originally published in 2023, this document aims to clarify key terms and concepts 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 shared understanding of these terms is essential for the effective and consistent implementation of the vigilance requirements under both Regulations.
The document is intended for competent authorities, economic operators, and other relevant parties. Some definitions presented here are adapted from the Guidelines on a Medical Devices Vigilance System, with modifications where necessary to align with the MDR and IVDR.
The changes that have been made to the guidance document include the following:
Amendment to Footnote 8:
- This footnote has been updated to align with Regulation (EU) 2024/1860, which amends the existing Regulations (EU) 2017/745 (Medical Devices Regulation) and (EU) 2017/746 (In Vitro Diagnostic Devices Regulation).
- The changes brought by this regulation pertain to the gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices
Amendment to Question 21:
- The term ‘EUDAMED vigilance (VGL) module’ has been revised to ‘EUDAMED Post-market Surveillance and Vigilance module (VGL module)’.
Amendment to Footnote 34:
- The phrase ‘48 working hours’ has been replaced with ‘allow 48 hours (equivalent to two weekdays)’.
The updated guidance document can be accessed using the following link
