The European Commission’s Medical Device Coordination Group (MDCG) issued new guidance providing recommendations for integrating unique device identification (UDI) processes within a manufacturer’s quality management system (QMS) to meet requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).


“The purpose of this document is to provide guidance on the integration of the UDI and the implementation of the UDI obligations as part of an organisation’s [QMS] as required by Article 10(9)(h) MDR and 10(8)(h) IVDR,” MDCG writes, noting that manufacturers need to consider how the UDI system and related obligations can be integrated into their QMS.


MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system