EUDAMED Actor Registration: What Importers Need to Know
- Ashley Sanchez
- Apr 29, 2025
- 1 min read
!! Attention EU Partners !!
Under the European Union Medical Device Regulation (EU MDR 2017/745, Article 31), certain economic operators—including manufacturers, authorized representatives, and importers—are required to register in the Actor Registration Module of EUDAMED, the European database on medical devices.
Registration is currently voluntary, but it is expected to become mandatory in Q1 2026.
When the requirement becomes mandatory, each actor must obtain a Single Registration Number (SRN), which will be used to identify them throughout the medical device supply chain.
Does This Apply to You?
If you are importing medical devices into the EU, then yes—you will need to register as an importer in EUDAMED and obtain an SRN.
This includes distributors who import into an EU member state even if they warehouse or operate out of a non-EU country.
How to Register as an Importer
If you haven't yet registered and need help, here are the basic steps:
Create an EU Login Account
Register for an EU login here:
https://webgate.ec.europa.eu/cas/eim/external/register.cgi
Access the EUDAMED Actor Registration Module
Visit the system here:
https://webgate.ec.europa.eu/eudamed
Select Your Role as Importer
Complete the registration form with your company’s information.
Upload Required Documentation
You’ll need to submit documents such as your business license or VAT certificate.
Approval by National Competent Authority
The application will be reviewed by the competent authority of the country in which you are based or operate. Once approved, your SRN will be issued.
For detailed instructions, consult the official EUDAMED Economic Operator User Guide here: Download User Guide (PDF)
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