EUDAMED - Current Status of the Database for Medical Devices

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

On 26 May 2021, the starting date of the application of Regulation 2017/745 for medical devices, the European Commission published some Questions & Answers. The Q&As are related to the requirements and tools for the safety of medical devices, including EUDAMED.

EUDAMED - Database for Medical Devices

The medical devices database, EUDAMED, is set to provide an overview of all medical devices available in the European Union. It will include various electronic systems with information about medical devices and the respective companies (e.g. manufacturers). EUDAMED consists of a total of six modules related to the following:

• actor registration,
• unique device identification (UDI) and device registration,
• notified bodies and certificates,
• clinical investigations and performance studies,
• vigilance,
• market surveillance

According to the European Commission, the development of EUDAMED is progressing. The first EUDAMED module for actor registration went live in December 2020. The Commission is still working on the other modules and plans to release, for example, the UDI module and the notified bodies & certificates module in the second half of 2021. Currently, the Commission is exploring the possibility of a step-by-step release of the other modules.

For more information, see the European Commission's Questions & Answers: Application of Regulation on Medical Devices - EU rules to ensure safety of medical devices.