EUDAMED - Actor registration

Eudamed is the European Database on Medical Devices.The European Commission plans for the various modules of Eudamed to be made available gradually, with full deployment scheduled for the second quarter of 2027 . This database will consist of 6 interconnected modules :

 

• Actors module : dedicated to identifying economic operators. These actors will have to identify themselves before making their medical devices available on the market (Art. 30-31 MDR-2017/745 and Art. 27-28 IVDR-2017/746). This module has been available on a voluntary basis since December 2020.
• Devices module : for registering different medical devices (Art. 28-29 MDR-2017/745 and Art. 25-26 IVDR-2017/746). This module has been available on a voluntary basis since October 2021.
• Certificates module : dedicated to the registration of notified bodies and certificates issued by them (Art. 57 MDR-2017/745 and Art. 52 IVDR-2017/746). This module has been available on a voluntary basis since October 2021.
• Clinical investigations module : for the registration of clinical investigations (Art. 73-74 MDR-2017/745) and performance evaluations (Art. 69-70 IVDR-2017/746).
• Vigilance module : for all post-market vigilance and surveillance reports (Art. 92 MDR-2017/745 and Art. 87 IVDR-2017/746).
• Market surveillance module: dedicated to the coordination of market surveillance actions between the different competent authorities (Art. 100 MDR-2017/745 and Art. 95 IVDR-2017/746).

 

 Most of the information in the Actors, Devices and Certificates modules is publicly available. Access to information in the other modules (Clinical investigations, Vigilance, Market Surveillance) will be limited publicly.

Until Eudamed is fully functional (second quarter 2027), registration in the actor module is voluntary.

The actor module is reserved for certain economic operators :

• within the European Union (+ Iceland, Liechtenstein, Norway, Turkey, Northern Ireland) : manufacturers, authorised representatives, systems and procedure pack producers and importers.
• outside the European Union: manufacturers. These actors must have an authorised representative located within the European Union (+ Iceland, Liechtenstein, Norway) registered on Eudamed.

All the actors listed above can register regardless of the devices they make available on the EU market (MDs in accordance with Dir. 93/42 or 90/385 or Regulation 2017/745, in vitro diagnostic MDs in accordance with Dir. 98/78 or Regulation 2017/746).

The actor module can be accessed using the following link : https://webgate.ec.europa.eu/eudamed

Until Eudamed is fully functional, registration in the actor module is voluntary. Once the Commission publishes the notice in the Official Journal of the European Union announcing that the Eudamed database is fully functional (second quarter 2027), registration of actors in the database will become compulsory. Actors will however have 6 months to register. This means that by the fourth quarter 2027, all actors will have to be registered in Eudamed.

There is currently no legal obligation to register in Eudamed. Eudamed is scheduled to go into full production by the second quarter 2027. The obligation to be registered will become effective 6 months after the production start date. This means that if you register today, you won't need to do so when it becomes compulsory.

The FAMHP national databases communicate with Eudamed. Once registered, the Eudamed data becomes the actor's master data and the FAMHP online applications will search for updates directly in Eudamed.

 

Registering with Eudamed also enables you to obtain your SRN (Single Registration Number), which is your unique identification number (see question 5).

 

Registration as an economic operator in Eudamed is a prerequisite for using the database's other modules.  

The SRN (Single Registration Number) is a unique identification number. An SRN is assigned to each role of an actor (manufacturer, authorised representative, importer, systems and procedure pack assembler). A company performing different roles can therefore have several SRNs.

The SRN is generated by Eudamed and issued via Eudamed by the competent authority that validated the actor's registration application.
Once the application has been validated by the competent authority (FAMHP for Belgian actors), the economic operator is notified by e-mail that the SRN has been issued. The SRN is not included in the e-mail, but is available via a link to an Eudamed page.

The SRN guarantees the identification of economic operators at European level. Together with the MDR and IVDR, this number must be included in various documents such as declarations of conformity, technical documentation and certificates issued by notified bodies.   

Yes. The "public" section of the actor module has been available since 1 December 2020. This is the link to access it: https://ec.europa.eu/tools/eudamed/#/screen/home

 

No, distributors cannot register on Eudamed. Consequently, there is no SRN for distributors.

Belgian distributors or distributors operating on Belgian territory must register their activity on the FAMHP web portal. The details of this obligation are set out in the Royal Decree of 15 November 2017 on the materialovigilance contact point within hospitals and the registration of medical device distributors. Access to the FAMHP web portal : https://www.vas.ehealth.fgov.be/webmedseip/en/

No, Belgian manufacturers of custom-made devices do not have to register on Eudamed. However, they are obliged to register their activity and their manufactured devices on the FAMHP web portal (Article 15 of the Law of 22 December 2020)

For more information on this subject : https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/manufacturers/custom_made_devices

Access to the FAMHP web portal : https://www.vas.ehealth.fgov.be/webmedseip/en/

• The VAT number: we use this number to match the data with the Crossroads Bank for Enterprises (CBE).
• The 'signed declaration’document(declaration on information security responsibilities) : the purpose of this document is to appoint a local actor administrator (LAA) who will be responsible for the "administration" of the data in Eudamed. This declaration must be correctly completed and signed by a legal representative of the company..

No. Actors wishing to register on Eudamed must do so via the Eudamed website even if they are already registered on the FAMHP web portal.

The data registered on Eudamed is automatically imported into our database, which is then, if necessary, updated according to the Eudamed data (Eudamed being considered, along with the CBE, as one of the authentic sources of information). Information not available on Eudamed about the details of activities such as the addition of other establishment units or risk classes must however still be encoded/updated using the FAMHP web portal.

No. For actors based in Belgium, the data recorded on Eudamed is automatically imported into our database. Information not available on Eudamed about the details of activities such as the addition of other establishment units or risk classes must however still be encoded/updated using the FAMHP web portal.

The European Commission publishes guidance on many subjects, including Eudamed. These guidances are available via the following link :

https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

 

The European Commission has created a web page specifically dedicated to the Eudamed actor module. The site contains a wealth of useful information (SRN documentation, registration procedure manual, FAQ, etc.) : https://health.ec.europa.eu/medical-devices-eudamed/actor-registration-module_en