EUDAMED - The database in the sense of the MDR
Central electronic database contains information on manufacturers, Notified Bodies, clinical trials, certificates and market surveillance
As required by the MDR (Medical Device Regulation), a central electronic database, the EUDAMED (European Database for Medical Devices), will display all relevant information on manufacturers, Notified Bodies, clinical studies, certificates and market surveillance, thus ensuring traceability.
The EUDAMED database
While the MDR only described an electronic database, the EUDAMED database is already an implementation of this requirement. It serves to exchange of information, the filing of evidence and as an increase of transparency.
The new database will not be limited to Europe, but will provide worldwide access to all public information. This public information includes, but is not limited to
- Information about the manufacturer, authorized representative, importer:
- contact details
- Information on the medical device, e.g:
- risk category
- effective date
- Link to certificate
- for Class III products: the Summary of Safety and clinical performance (SSCP)
- Summary of manufacturers (Class III and implants):
- A document that bundles the safety aspects and performance of medical devices and the results of clinical trials.
- Information from the Notified Bodies:
- List of fees for conformity assessment procedures
- List of branches
It is free of charge for manufacturers and persons who should use this database according to MDR.
What data is stored?
The EUDAMED stores:
- Data on the manufacturer or authorised representative
- Information about the products (SRN, Singe Registration Number)
- Information concerning the certificates
- incident reports
- Information on clinical trials
Detailed information can be found on the website of the Johner-Institut.
The database is expected to be operational in March 2019 and ready for use in September 2019.