EUDAMED - Actor registration

• manufacturers within the European Union and Iceland, Liechtenstein, Norway, Turkey, Northern Ireland;
• manufacturers outside the European Union;
• authorised representatives;
• procedure pack producers;
• importers?

Other actors may also be concerned by registration in the Eudamed actor module due to registration obligations arising from other Eudamed modules, namely:

• manufacturers of custom-made devices if the custom-made device is subject to post-market surveillance or vigilance activities;
• manufacturers of Class III custom-made implantable devices, to enable notified bodies to register the necessary quality system certificate (Article 52 (8) of the MDR);
• sponsors of clinical investigations or performance studies, for example, to request a clinical investigation or report a serious adverse event.

The different Eudamed modules will gradually become mandatory. Registration of actors will be mandatory 6 months after the date of notification in the Official Journal of the EU that Eudamed actor module is functional (more information on the current timeline on our dedicated Eudamed page ). However, since 2020, registration of actors (others than sponsors) can be done on a voluntary basis.

There is currently no legal obligation to register in Eudamed. Registration of actors will be mandatory 6 months after the date of notification in the Official Journal of the EU that Eudamed actor module is functional (more information on the current timeline on our dedicated Eudamed page ).However, 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) or an Acotr ID, which is the unique identification number (see question 5).

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

Only manufacturers, importers, authorised representatives, and system and procedure pack producers who are not required under the MDR or IVDR to use other EUDAMED modules are exempt from registration.

For example, a manufacturer who no longer places devices on the market at the time when the device registration module becomes mandatory does not need to register, unless they are required to submit a post-market surveillance or vigilance report for one of their devices

The SRN (Single Registration Number) is a unique identification number. An SRN is assigned for each role listed in Article 31 of the MDR or Article 28 of the IVDR that an actor performs (manufacturer, authorised representative, importer, systems and procedure pack producer). A company performing different roles can therefore have several SRNs. For system and procedure pack producers and custom-made device manufacturers, this is not an SRN but an Actor ID (however, the principle is exactly the same and the code structure is the same).

The SRN/Actor ID 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), an e-mail generated by Eudamed notifies the economic operator that the SRN/Actor ID has been issued. The SRN/Actor ID is not included in the e-mail, but is available via a link to an Eudamed page.

The SRN/Actor ID 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/Actor ID 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.

Belgian manufacturers of custom-made devices, like those in the European Union, are only required to register in the following cases:

• If they place implantable class III custom-made devices on the market, in order to allow their notified body to register the certificate of their required quality system (Article 52(8) of the MDR;
• If they need to report a post-market surveillance or vigilance action in Eudamed for one of their custom-made devices.

Outside of these cases, 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)

More information on this subject on the dedicated page for custom-made devices

• 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..

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