Eudamed: Mandatory Registration from December 2020

From December 1, 2020, manufacturers, authorized representatives, system and procedure pack producers, and importers must register in the Actor registration module (the first of Eudamed’s six modules).

Following the verification of the entered data, Eudamed will generate a Single Registration Number (SRN), notified via email.

Single Registration Number

The SRN must be obtained before requesting the notified body to start the CE marking process, or – if the body’s intervention is not required – before placing a medical device on the market.

The manufacturer enters this Single Registration Number in their application to the notified body for conformity assessment and for access to Eudamed.

The Single Registration Number is composed as follows:
IT (country code) – MF (role abbreviation) – 000000001 (nine-digit progressive number)

Role abbreviation: manufacturer (MF), authorized representative (AR), system and procedure pack producer (PR), importer (IM).

Data Required for Registration

For registration in the Actor registration module, the following data must be entered:

• Type of economic operator (manufacturer, authorized representative, system and procedure pack producer, or importer);
• Name, address, and contact details of the economic operator;
• When the information is provided by another person on behalf of one of the economic operators mentioned in the first point, name, address, and contact details of that person;
• Name, address, and contact details of the person or persons responsible for regulatory compliance;
• Declaration of responsibilities regarding information security;
• Summary document of the authorized representative.

The above data is publicly accessible.

Periodic Confirmation and Updates

The economic operator confirms the accuracy of the data within one year of submitting the information and subsequently every two years.

In case of changes to the registered information, the economic operator must update the data in the electronic system within one week.

Registration Support

Starting from December 1, 2020, we will be available to initiate the registration process for economic operators in Eudamed’s Actor registration module. Use the details in the contacts section.