Updated! Medical Device Coordination Group vigilance Q&A document  

Posted on 05.12.2024

The Medical Device Coordination Group (MDCG) 2023-3 Question & Answer document on vigilance terms and concepts has been updated to adapt it to the In Vitro Diagnostic Medical Devices Regulation (IVDR). Previously, the document has been only dedicated to Medical Device Regulation (MDR). The document is therefore now officially applicable for both regulations MDR and IVDR.  

Amongst other things, the document has been enriched with examples for the In Vitro Diagnostics (IVD) sector and the quality of the Q&A document has been improved with several general changes applicable to both sectors.   

The Q&A document provides a support to manufacturers by establishing a common understanding of vigilance terms and concepts outlined in these regulations which enables a more effective and harmonised implementation of the vigilance requirements. 

The updated MDCG document can be found here.  

For more information, please contact Vaida Jukneviciute, Manager In Vitro Diagnostics.