The Representative of choice for
Economic operators must register in EUDAMED, namely importer, EU & non-EU manufacturers, system and procedure pack producer and authorised representative. Member States, notified bodies, and sponsors must also enter data into the database. Although EUDAMED registration is still not mandatory, manufacturers are highly encouraged to register as actors and their devices. Indeed, some Competent Authorities are envisaging waving the national notification obligation for devices registered in EUDAMED.
The registration of all devices will become mandatory within 24 months after the Commission publishes a notice that EUDAMED is fully functional (or immediately in case of incidents).
EUDAMED has six different modules, of which currently the first three are active:
- Actor registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
The manufacturer should register first as an actor and then proceed to the device registration. To register, manufacturers need to create an account and accurately fill the required information.
To register the device information in EUDAMED, manufacturers must:
- Ensure the devices comply with the applicable legislation (MDR/IVDR).
- In the case of non-EU manufacturers, sign a Mandate with the Authorised Representative.
- Complete the actor registration.
- Enter the device information in the Device Module, following the user guide provided by the EU Commission.
After completing the registration, the Authorised Representative must verify the UDI and Device information registration in EUDAMED performed by the non-EU manufacturer.
The first registration is the actor registration. Manufacturers will add certain data on their company, such as address, regulatory person information, and company identification details. Afterwards, the Authorised Representative will verify the registration before the Competent Authority’s validation. With this registration, manufacturers will receive the SRN number, required by notified bodies for the conformity assessment procedure.
Alternatively, Obelis can assist the manufacturer in the EUDAMED registration process, leading to fast validation and SRN number issuance.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
