MDCG Guidance note: UDI within organization’s QMS

The MDCG has released a new Guidance note on how to implement the MDR / IVDR requirements related to the Unique Device Identification (UDI) system within the Quality Management System (QMS) of a manufacturer, an economic operator or a person assuming the obligations of the manufacturer according to Article 16(1) MDR/IVDR and Article 22(4) MDR.

Firstly, the MDCG highlights that the UDI and Basic UDIDI assignment, and management of the UDIrelated information, can impact many other lifecycle QMS processes (MDCG, 2021) and advises the manufacturer to generate a UDI implementation plan (elements listed below) and QMS implementation tools, while properly documenting to ensure compliance with the Regulation.

  • 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 UDIrelated QMS processes can be verified.

When identifying and documenting external roles, such as AR, importers, distributors, applicable UDI responsibilities shall be assessed.

Furthermore, the MDCG enlists the following sections to be considered – please read the Guidance note for a detailed analysis:

  • Design and Development
  • Product documentation and retention
  • Production and process
  • Serious incidents and field safety corrective actions
  • Purchasing controls
  • Documentation and records
  • Enterprise Resource Planning
  • UDI data to be provided to EUDAMED database

Appendix I QMS process implementing UDI at the manufacturer’s site

Appendix II Example of a UDI implementation plan

We highly advise you to read the full Guidance note in order to correctly implement the UDI requirements within your QMS!

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