Covering the whole European Union, EUDAMED (European database for medical devices) is the European Commission’s best tool to assess economic operators and medical devices present on the EU market. Nevertheless, EUDAMED is currently not fully functional, causing confusion for manufacturers on what is expected from them.
First, the EUDAMED platform consists of six interrelated modules to submit data on:
- Actors (currently available);
- Devices (now available);
- Notified bodies and Certificates (now available);
- Clinical Investigations and Performance Studies (under development);
- Vigilance and Post-market Surveillance (under development);
- Market Surveillance (under development);
What do I need to do as a manufacturer?
In the first place, manufacturers should know that the EUDAMED database was expected to achieve full functionality by the 2nd quarter of 2024, the time upon which all 6 EUDAMED modules will be released. The most essential date is the moment the database is recognized to be fully functional. Why? Because from this time onwards, there will be a 6 month period for manufacturers to comply and register the data on:
- Economic operators/Actors;
- Clinical Investigations and Performance Studies;
- Vigilance and Post-market Surveillance;
- Market surveillance module will also become mandatory at that time.
While there is 24 month transitional period after the full functionality notice to submit data to the modules on:
- Devices/Unique device identification
- Notified Bodies and Certificates;
Even if EUDAMED is not yet mandatory, manufacturers are advised to register as economic operators in EUDAMED as soon as possible, as EU Competent Authorities have indicated that they consider the actor registration as already applicable. Moreover, the Single Registration Number (SRN) that manufacturers receive after the actor registration is required when applying to a notified body for an MDR CE Certificate and to access EUDAMED to fulfil the device registration obligations.
How do I register as an actor on EUDAMED?
The process is not complicated! The manufacturer must log in to the EUDAMED database and introduce the appropriate information (company name, address details, PRRC details, etc.). Once all information is completed, the submission is verified by the Authorised Representative for non-EU manufacturers and validated by the EU Competent Authority.
Upon successful verification, the actor will receive an Actor ID or Single Registration Number (SRN) that uniquely identifies every economic operator in EUDAMED. This SRN is necessary for the registration of the devices in the platform.
Devices registration
Manufacturers must register their device information in EUDAMED. Beforehand, non-EU manufacturers need an MDR/IVDR Mandate signed with an Authorised Representative and to have completed the actor registration.
A different registration procedure is required for the following devices:
- MDR/IVDR devices;
- MDR/IVDR legacy devices;
- System or Procedure Pack devices;
Apart from EUDAMED, is there any other registration necessary?
Despite the implementation of the EUDAMED database, national registrations remain mandatory in certain EU Member States. Therefore, it is essential to assess:
- In which countries national registration is required;
- For which devices it has to be performed;
- Which economic operator has to carry it out;
- Which operators need to notify the authority of their activity on the national territory.
It is also important to mention that certain national registrations will stop being compulsory upon the full implementation of the EUDAMED database.
Not performing national registration requirements will lead to the lack of compliance of the device with current legislation, which might involve penalties or recalls of the device placed on the market.