European Commission released 8 documents for unique device identifiers (UDIs) for medical devices

The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices.

4 of them are relating to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose.  These UDI-DI documents are from GS1, HIBCC, ICCBBA and IFA respectively. The other 4 documents would deal with UDI human readable interpretation (HRI) formats, including HRI qualifiers for UDI-DI, lot number, expiration date, serial number and manufacturing dates.

More details can be found in the EC website:
https://ec.europa.eu/docsroom/documents/35241?locale=en
https://ec.europa.eu/docsroom/documents/35242?locale=en

European Commission’s aide memoire

Europe, the European Commission released an aide memoire to assist pharmaceutical wholesalers in practicing good distribution practice (GDP). The 6 page document ranges from a form of general questions to specific questions relating to quality systems, verification of a medicine’s safety features, suspected falsified medicinal products and decommissioning of unique identifiers (UIs).

More details are in the link on the first comment.

https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/inspection_gdp_aidememoire_en.pdf

Eudamed upcoming plans

The European Commission database of Medical Device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been done.

They have decided to launch the database simultaneously for both medical devices and in-vitro diagnostics come May 2022.

This means that device manufacturers can now postpone their entering of data into Eudamed.

As compared to the current database, the new Eudamed2 will contain different modules

  • Actors
  • Unique Device Identifiers
  • Notified bodies and certificates
  • Vigilance clinical investigation performance studies
  • Market surveillance