Europe: Development of Eudamed Well on Schedule
EMERGO SUMMARY OF KEY POINTS:
- Eudamed functional specifications expected to be released in May of this year
- Eudamed expected to go live in March 2020
- As with all plans: there are some uncertainties regarding the execution of this plan
European regulators appear on track to launch the Eudamed database for medical devices in March 2020, but stakeholder accessibility may take longer than that.
The European Commission understands the European Database for Medical Devices, Eudamed, will be essential for the functioning of the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe. This database, consisting 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. That “general public” will not be limited to European citizens; anybody in the rest of the world will have the same level of access.
Because Eudamed will be used for permanently monitoring safety and performance of devices and providing transparency in the distribution chain, frequent interaction with Eudamed will be required by all economic operators involved.
Eudamed’s highly intense data management requires clear rules of what and when to upload or verify. These rules are currently being developed, and they will be summarized in the functional specifications. Since the beginning of 2017 the European Commission has worked together with experts sitting on the Eudamed Steering Committee and several working groups to define these specifications. In the meanwhile work has started on developing the interfaces needed for smooth operation of Eudamed.
Recently the Steering Commission’s Eudamed team presented the planning for the remaining database development work. It is expected that Eudamed will go live in March 2020, within the timeline required by the MDR. The current roadmap is as follows:
- 15 March 2018: MDCG accepts the functional specifications of the first set of modules (actors, UDI/Devices, Notified Body/Certificates)
- May 2018: The first functional testing starts
- 25 May 2018: MDCG accepts all functional specifications. This is in compliance with article 34.1 of the MDR.
- Q1 2019: Further functional testing
- May 2019: Public site
- September 2019: Eudamed is ready for the formal audit
- March 2020: Eudamed goes live
Is this planning feasible?
The planning up until release of the functional specifications in late May 2018 appears feasible. A lot of work has been done and draft specifications are already circulating internally for review. However, it is not clear how straightforward the step from specifications to functioning database will be. With the complex requirements of the MDR and IVDR it is very well possible that rare combinations of devices, economic operators and/or requirements have been overlooked, leading to an incorrect handling in Eudamed.
Even if Eudamed can go live as planned, it is far from certain all economic operators will be able to get access to the database in time. Now, only economic operators, sponsors and Notified Bodies with a Single Registration Number (SRN) have access to Eudamed. Applicable Competent Authorities grant SRNs. Unless these authorities have started in advance, it will likely take a significant amount of time after the March 2020 go-live date before all SRNs are issued. This may cause a conflict with Article 123.3(d) of the MDR that 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. The bottleneck especially applies to devices that require new certification under the MDR.
Another bottleneck may be the free availability of an internationally recognized medical device nomenclature by the European Commission. MDR Article 26 requires this nomenclature, but so far it is not certain what nomenclature will be used.
And of course there are the unforeseen risks that may throw a spanner in the wheels of Eudamed. Whatever happens, it looks as if Eudamed is here to stay and will play a vital part in medical devices compliance monitoring, even if a delay in the development occurs.