EUDAMED is the European Databank on Medical Devices. It is a collection of databases and electronic systems established by the new EU MDR for collecting data. It is expected to act as an information system for exchanging legal information. The information system is related to the application of European Union directives on medical devices between the European Commission's Enterprise, and Industry Directorate General and the Competent Authorities in the European Union Member States
Purpose of EUDAMED
- To enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators
- To enable unique identification of devices within the internal market and to facilitate their traceability
- To enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81
- To enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91
- To enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them
Features of EUDAMED Database
- Registration of devices
- UDI-database
- Registration of economic operators
- Notified bodies accreditation and certificates
- Clinical investigations
- Vigilance and post-market surveillance
- Market surveillance
EUDAMED Timeframes
- The specifications for the first set of modules were accepted on May 26, 2018
- EUDAMED is expected to go live by March 25, 2020
With the implementation of EUDAMED, the face of medical device registration in EU is going to change. For assistance on registration of medical device in EU, reach out to us at sales@freyrsolutions.com.