EUDAMED registration: requirement under MDR 2017/745 and IVDR 2017/746

EUDAMED registration is a mandatory condition that economic operators who are involved in the circulation of medical devices in the European Union must fulfill.

What is EUDAMED

EUDAMED is the European medical device database. EUDAMED registration is a requirement of the EU Medical Device Regulation MDR 2017/745 (art. 29-31 p. 4) and the EU In Vitro Medical Device Regulation IVDR 2017/746 (art. 26-28 p. 3).

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The database consists of the following modules:

• Actors registration (registration of economic operators)
• UDI/Devices registration (registration of medical devices)
• Notified bodies and certificates
• Clinical Investigations and performance studies
• Vigilance and post-market surveillance
• Market Surveillance

Who must register in EUDAMED

EUDAMED registration is mandatory for:

• Authorized Representatives
• Manufacturers of medical devices, including legal manufacturers and system and procedure packers
• Importers of medical devices

It is important to note here that all manufacturers must register in EUDAMED, whether they are located in the EU or outside the EU. If the manufacturer is located outside the European Union, it is necessary that at the time of EUDAMED registration, their authorized representative is already registered in EUDAMED. Otherwise, the registration of a non-European manufacturer in EUDAMED will not be possible.

If an economic operator performs several functions at once (for example, manufacturer and authorized representative), he must be registered in each of the roles.

Distributors of medical devices are not required to register in EUDAMED. However, if the distributor is also acting as an authorized representative or importer, which is not uncommon, he must register with EUDAMED in this role. Besides, MDR and IVDR allow the national authorities to maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.

Documents required for EUDAMED registration

To register in EUDAMED a manufacturer must provide (upload to the system) two documents:

• Declaration on information security responsibilities - a declaration that the manufacturer is responsible for the information management
• Mandate Summary document - a document that describes the rights and obligations that the manufacturer gives to its authorized representative.

The result of EUDAMED registering: SRN - Single Registration Number

After passing all stages of EUDAMED registration, a manufacturer receives the Single Registration Number, better known as SRN. This number becomes the main identifier for the manufacturer of medical devices in the European Union. It is included in the technical documentation, used in reporting incidents, in bidding and procurement procedures, etc.

If the manufacturer is located outside the EU, after filling out all the forms on the EUDAMED portal, an application is formed on his behalf and sent to his authorized representative. Only after the authorized representative approves this application, the non-European manufacturer will receive its SRN.

If an economic operator registers in several roles (for example, manufacturer and authorized representative), for each of these roles he receives a separate SRN.