Currently, EUDAMED is used for the exchange of information between EU Member States and the European Commission. However, with the entry in force of the Medical Devices Regulation (MDR) in 2021 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) in 2022, a new version of EUDAMED is introduced.
The new version of EUDAMED is a multipurpose system that contains information about medical devices, supervising entities and economic operators (“Actors”). The new EUDAMED will also be open to the public.
More specific, the new version of EUDAMED will consist of a public site and the following six interconnected modules:
- Actor and user registration and management
- UDI database and registration of devices
- Certificates and Notified Bodies
- Clinical Investigation and performance studies
- Vigilance and post-market surveillance
- Market surveillance
With this new system, the European Commission expects to improve transparency and coordination of information regarding medical devices available on the EU market.
How does this Actor registration module work?
The Actor registration module enables economic operators – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers - to submit, by means of an Actor registration request, the information necessary to obtain a single registration number (SRN). The SRN guarantees a EU-wide unique identification for economic operators. Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the SRN of the economic operator to the national competent authority and transfers it to the requesting economic operator. An economic operator has to obtain a separate SRN for each Actor role it performs.
For non-EU manufacturers, its authorised representative verifies the registration request before passing it to the national competent authority for assessment.
In the process of registration, every Actor appoints a person that manages “Actor data” and “Actor notification email addresses” and that has the power to accept request from others within Actor’s organization to get access to EUDAMED. This person is called the first Local Actor Administrator (“LAA”). The European Commission strongly recommends having at least two LAAs to avoid the situation in which first LAA is not able to respond to user access requests resulting in no one being able to access EUDAMED.
Time for action?
Even though the Actor registration module will be made available on 1 December 2020 and the Medical Device Coordination Group strongly encourages the use of the Actor registration module by all relevant Actors on their territories, using the module is not obligatory as of 1 December 2020 nor when the MDR enters into force on the 26st of May 2021. The MDR provides that, since EUDAMED will not be fully functional on 26 May 2021, the obligations and requirements that relate to EUDAMED shall apply six months after the date of publication of the European Commission’s notice thereto in the Official Journal of the European Union.
In conclusion, use of EUDAMED is encouraged, but it remains to be seen when using EUDAMED becomes mandatory for economic operators. Therefore, no immediate action is required as of 1 December 2020. It is, however, possible that Member States will require Actors to register themselves using the Actor registration module well before the other modules are made available.
Authored by Hein van den Bos, Karen Jelsma, and Wouter van Beek
