EUDAMED

Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The system is a collection of databases and electronic systems. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and interoperable.

EUDAMED has six interconnected electronic systems and a public website:

Purpose of EUDAMED:

Information stored in EUDAMED:

Depending on the applicable directive, EUDAMED contains data:

Actor Registration:

1st December 2020, the European Commission has made available the Actor registration module. It is the first of six EUDAMED modules.

The actor module is key to accessing and using Eudamed, which allows economic operators to obtain a single registration number (SRN) that provides an EU-wide unique identification.

The actor module also contains a searchable database of registered actors, i.e., economic operators and competent authorities. Actor’s information such as contact information and identification, and for manufacturers, information about the companies’ responsible persons for regulatory compliance can be found on the database.

What are different Actor Roles?

Supervising Entity:

Economic Operators:

 *Distributors are not registered in EUDAMED.

To use EUDAMED, you must have an EU Login account – linked to your work email address.

SRN (Single Registration Number): The Single Registration Number (SRN) uniquely identifies every economic operator in EUDAMED. The SRN is issued once the relevant competent authority has validated the Actor registration request.

The economic operator will get a unique SRN for each actor role. If the economic operator has multiple roles, separated registration requests are required to obtain a different and specific SRN for each actor role.

2 ways to register in the EUDAMED:

1 – REQUEST REGISTRATION FOR AN ECONOMIC OPERATOR

Information required for registration:

2 – REQUEST ACCESS AS A USER OF A REGISTERED ECONOMIC OPERATOR

OMC Medical will  help you with all the registration activities in EUDAMED; to know more please contact us at [email protected]