MDCG publishes guidance on integration of UDI and QMS

MDCG 2021-19, ‘Guidance note integration of the UDI within an organisation’s quality management system’, has now been published by the Medical Device Coordination Group (MDCG), detailing its advice on how, when implementing the requirements of the MDR/IVDR related to its QMS, manufacturers should consider how the UDI system and related MDR/IVDR obligations should be integrated.

The guidance proposes that manufacturers should establish a UDI implementation plan, and use appropriate implementation tools from its QMS to allow correct assessment/decisions to be made and the proper documented evidence to be created, to ensure compliance with the Regulations regarding the UDI system. It goes on to suggest that elements of such a plan may include:

• analysis of expectations and needs of different stakeholders such as economic operators, healthcare institutions/professionals, patients/users, insurance providers;
• analysis of the relevant issuing entities’ standards;
• choice of a designated issuing entity;
• definition of internal responsibilities for the implementation and subsequent management of the project plan;
• management and, if necessary, updates of the project plan implementation;
• description of methods and use cases, by which the proper running and continuous compliance of UDI-related QMS processes can be verified.

The guidance also suggest that manufacturers may also assess the applicable UDI responsibilities when determining and documenting external roles (e.g. third party suppliers, authorised representative, importers, distributors, systems and procedure pack producers).