April 7, 2023

EU MDR Basic UDI-DI “essential design and manufacturing characteristics”

According to the MDCG (2018-1), the Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.  While this definition is a departure from the official definition in the EU MDR and IVDR, the Commission appears to have endorsed it nonetheless when the Commission used that definition in its 01/08/2020 ‘What you need to know!’ / FAQ document on UDI. I’ve also see notified bodies like BSI endorse the MDCG definition.

Since for this context the EU MDR and IVDR don’t actually define what is meant by “essential design and manufacturing characteristics“, we seem to be left with some liberty in how to interpret that phrase when approaching the Basic UDI-DI.  This becomes particularly important when grappling with whether a device change requires a new Basic UDI-DI.

ComplianceAcuity’s recommended approach is to assess the impact of a change on the Annex II Section 3 technical documentation (Design and Manufacturing Information).  If a device or manufacturing change is made that significantly affects that Section, then there is a good chance that a new Basic UDI-DI is needed.  I would also go further and say that if there is a significant impact on the conformity information used for Annex II Section 4 (General Safety and Performance Requirements) (e.g., in the GSPR checklist) with regard to the GSPR(s) related to device design and manufacturing, then that would also be an indication of an impact on the Basic UDI-DI.