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.