Economic operator/Eudamed Registration

1- PURPOSE:

The purpose of this procedure is to identify the economic operators and define their roles.

2- SCOPE:

This procedure covers all process in OPTALINE.

3- RESPONSIBILITY:

QA Manager

4- DEFINATIONS:

4.1 Economic Operator: “a manufacturer, an authorized representative, an importer, a distributor”.

4.2 Actor: is a natural or legal person with a specific role that has to be registered in EUDAMED.

Note that Distributors are not registered in EUDAMED.

4.3 Eudamed: The European Databank on Medical Devices, It’s a web-based portal used for the
exchange of information between national competent authorities and the European Commission.

4.4 SRN: is the Single Registration Number / Actor ID that uniquely identifies every economic operator
in Eudamed and in the relevant official documents and related reports.

4.5 Placing on the market: The first making available of a device other than an investigational devic e.

5- PROCEDURE:

Manufacturers: responsible for Eudamed registration, technical documentation, design, development

manufacture and assembly, handling, storage and distribution, corrective actions, UDI labeling,
complaints, post market surveillance(PMS) and the PRRC.

Authorized Representatives: responsible for Eudamed registration, technical documentation, corrective

actions, UDI labeling, post market surveillance and PRRC.

Importers: responsible for Eudamed registration, handling, storage and distribution, corrective actions,
UDI labeling, post market surveillance(PMS).

Distributors: responsible for handling, storage and distribution, corrective actions, UDI labeling,
complaints and post market surveillance(PMS).

 Registration in Eudamed:
 The actor registration request for any manufacturer, authorized representative, importer or a
system/procedure pack producer should be verified and approved by a competent authority.
 For non-EU manufacturers, its authorized representative verifies the registration request before
passing it to the national competent authority for assessment.
 Economic operator/Eudamed Registration
 After The national competent authority approves the registration request, SRN is generated and
issued through EUDAMED.
 An email will notify the economic operator that the SRN has been issued via a link to Eudamed
page with the SRN value.
 If the economic operator has multiple roles (as example: manufacture and importer), separated
registration requests are required in order to obtain a different and specific Actor ID/SRN for
each actor role.

Example for SRN is BE-MF-000000001.