In June 2023, the European Commission (“EC”) released its comprehensive user guide for EUDAMED for UDI Devices. EUDAMED is the IT tracking system established by two very critical medical device regulations that have been a major focus in the medical device industry: (1) EU 2017/745 (“EU MDR) and (2) EU 2017/746 (“IVDR”). EUDAMED serves as a database tracker of the lifecycle of medical devices available throughout the EU, including information such as the authorized use, safety issues, recalls, and new relevant regulations (similar to the Global Unique Device Identification Database “GUDID” used in the United States which is administered by the FDA). The purpose of the database is to enhance transparency, provide better access to information regarding medical devices, and to facilitate communication among the EU Member States, with an overall objective of improving patient safety.
The new user guide is an extensive document including both videos and screen shots. The guide covers numerous topics, providing detailed, step-by-step instructions for User Profile Registration, Device Registration (including legacy devices), Registration of System or Procedure Packs (SPP), Management of Device Information, Management of SPP, Device Certification Information, and more.
As a reminder, EUDAMED is comprised of the following six modules:
- Actor Registration
- Unique Device Identification (UDI) and Device Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-Market Surveillance
- Market Surveillance
Some modules (Actor Registration, UDI and Device Registration, and Notified Bodies and Certificates) have been made available for voluntary use, however EUDAMED has not yet completed the independent audit required for it to be deemed fully functional. The timeline has been delayed with current projections of full functionality being the second quarter of 2024. Following the declaration of full functionality, mandatory implementation by manufacturers is expected to be staggered with certain modules required within six months and others within 24 months. However, steps to prepare for implementation continue to be taken by the EC including the earlier introduction of a new UDI Helpdesk to assist manufacturers navigate and comply with UDI system requirements, and also with the release of detailed user guides for EUDAMED.
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