On February 14th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices (MDCG 2023-03).
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. 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.
What does this mean to you?
MDCG 2023-03 is written for competent authorities, economic operators and other relevant parties involved in medical devices.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
