Eudamed functional specifications are expected to be released in May 2018, with Eudamed predicted to go live in March 2020. Eudamed is the European Databank on medical devices and European regulators appear on track to launch the Eudamed database in March 2020.
The purpose of Eudamed is to strengthen market surveillance and transparency in the field of medical devices, by providing national competent authorities with fast access to information. A further aim is to contribute to a uniform application of the Directives.
The European Commission has stated the importance of Eudamed for the functioning of the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe. The database, which consists of seven other databases (Economic Operators; Devices; UDI; Certificates; Clinical Studies and Performance Studies; Vigilance Data; and Market Surveillance), will be accessible to Competent Authorities, Notified Bodies, industry and the general public.
Frequent interaction with Eudamed will be required by all economic operators involved because Eudamed will be used for permanently monitoring safety and performance of devices and providing transparency in the distribution chain.
It is expected that Eudamed will go live in March 2020, within the timeline required by the MDR. The proposed roadmap is:
- 15th March 2018: Medical Device Coordination Group (MDCG) accepts the functional specifications of the first set of modules (actors, UDI/Devices, Notified Body/Certificates)
- May 2018: The first functional testing starts.
- 25th May 2018: MDCG accepts all functional specifications.
- First quarter of 2019: Further functional testing.
- May 2019: Public site.
- September 2019: Eudamed is ready for the formal audit.
- March 2020: Eudamed goes live.
However, even if Eudamed goes live as planned, it is not certain that all economic operators will be able to access the database in time. Currently Applicable Competent Authorities grant Single Registration Numbers (SRNs) which allow economic operators, sponsors and Notified Bodies access to Eudamed. Thus it is likely that it will take a significant amount of time after the March 2020 go-live date before all SRNs are issued.
This may create conflict with Article 123.3(d) of the MDR which requires manufacturers to obtain their SRNs three years after the Regulation enters into force and use those numbers for registrations in Eudamed and on CE Mark certificates.