How to Register on EUDAMED - step by step instruction

To register your organization on the European Union Database for Medical Devices (EUDAMED), follow these general steps. Before starting, ensure you have the following documents prepared and ready for upload during the registration process:

• AR Mandate Summary Document (see here): Required only for non-EU companies. Signed by the manufacturer.
• Declaration on Information Security Responsibilities (see here): Required for all companies. Declares commitment to responsible management of EUDAMED information.

Step 1: Create an EU Login Account

1. Visit the EUDAMED website (see here).
2. Click on "Create your EU Login account" and select "Create an account".
3. Fill in the registration form with your personal details using a corporate email address.
4. Submit the form. A confirmation email will be sent to your email address.
5. Follow the link in the email to set your password and complete your EU Login account setup.

Step 2: Create a New Actor

1. Navigate to the "Create new actor" section.
2. Select the appropriate options for your role (e.g., "Manufacturer") and country from the drop-down menus.
3. Enter your company name and confirm to proceed to the "Actor registration" page.

Step 3: Fill in Actor Identification

1. Select a language (e.g., English) next to your company name.
2. Enter your company’s abbreviated name (e.g., your trade name) and select a language (e.g., English).
3. Set VAT information to "No."
4. Leave the EORI number field blank unless applicable.
5. Enter your National Trade Register Number (or equivalent) and click "Save & next."

Step 4: Add Authorized Representative Details (For Non-EU Companies Only)

1. Check the box "I know the Actor ID/SRN."
2. Enter the Actor ID/SRN of your Authorized Representative and click "Find."
3. Confirm the details of the Authorized Representative displayed.
4. Under "Mandate validity," enter the mandate start date and leave the end date blank or provide it if applicable.
5. Upload the signed AR Mandate Summary Document.
6. Leave the checkbox "The Authorised Representative has the right to manage vigilance data for this manufacturer" unchecked.
7. Click "Save & next."

Step 5: Provide Actor Address

Fill in all mandatory fields (*) with your company’s address and click "Save & next."

Step 6: Enter Actor Contact Details

Complete all required fields (*) with your organization’s contact information and click "Save & next."

Step 7: Add Person Responsible for Regulatory Compliance

1. Enter the required details of the person responsible for regulatory compliance, including an email address from the corporate domain.
2. Check the box "Same address as the Actor organisation address" if applicable.
3. Click "Save & next."

Step 8: Register Local Actor Administrator

1. Review the pre-filled information at the top of the page.
2. Upload the signed Declaration on Information Security Responsibilities in the designated field.
3. Under "Are you a sub-contractor for this actor?", select "No."
4. Click "Save & next."

Step 9: Competent Authority

Review the page; no action is required here. Scroll to the bottom and click "Submit actor registration." Confirm the submission in the pop-up window.

What Happens Next?

For non-EU companies, your application will be sent to your Authorized Representative for review and approval. Once approved, the Authorized Representative will forward your application to the relevant regulatory authority. For EU companies, the application will be directly reviewed by the competent authority.