EUDAMED Actor Registration and the Single Registration Number

1. Key takeaways

Under Article 30 of the MDR, manufacturers, authorised representatives and importers must register their information in EUDAMED; distributors are not within the scope of registration; once registered, the system generates a Single Registration Number (SRN). Under Article 31, manufacturers, authorised representatives and importers (where placing devices on the market themselves or assembling systems or procedure packs) must complete device registration before placing the devices on the market. Commission Decision (EU) 2025/2371 declared the economic operators registration module functional, and it becomes mandatory from 2026-05-28. The practical consequence is a hard cut-over date: actor registration and device registration move from voluntary to compulsory, and placing devices on the market without completed registration becomes a visible non-compliance at market surveillance level. Companies should treat obtaining the SRN as an early project milestone, maintain a register of SRNs by role and entity, verify that their trading partners hold valid registrations, and keep the submission confirmations as compliance evidence, because the SRN links the actor, device and certificate records together across all downstream regulatory processes.

2. Legal basis

The registration obligations and the staged roll-out mechanism rest on the following instruments.

3. Expert insights

Insight one: the registration subjects are the manufacturer, the authorised representative and the importer — distributors do not register.

Article 30 lists the registration duty holders and does not include distributors. The European Commission’s official page states the same: EUDAMED will contain the registration information of economic operators (except distributors) and of devices. A company’s distribution network therefore does not need to register one by one, but it must ensure that the registrations of the three upstream role holders are valid. The distinction matters in contract and supplier management: distributors should be asked to evidence their manufacturers’, representatives’ and importers’ registrations rather than be asked to produce their own SRN, and procurement templates should reflect this division so that no party is asked for a registration the regulation does not require of it.

Insight two: the SRN is the primary key that links the records together.

The Single Registration Number (SRN) is used to associate the records of the manufacturer, the authorised representative, the importer, the devices and the certificates with the same entity. Under Article 11(3)(c), the authorised representative must also verify that the manufacturer has completed its registration obligations — and the object of that verification is precisely the SRN and the records linked to it. In day-to-day compliance work, the SRN therefore functions like a licence plate for every document a company submits, and any mismatch between the entity data behind an SRN and the information on declarations or certificates will surface during inspections or certificate applications.

Insight three: 28 May 2026 is the date the module shifts from voluntary to mandatory.

Commission Decision (EU) 2025/2371 was adopted on 2025-11-26 and published in the Official Journal of the European Union on 2025-11-27, declaring the electronic systems for economic operator registration (Article 30) and for the UDI database and device registration (Articles 28 and 29) functional and compliant with the functional specifications of Article 34(2). Under the transitional provisions of Regulation (EU) 2024/1860, that publication triggers a 6-month transitional period, and use becomes mandatory from 2026-05-28. Planning should assume that voluntary access ends at that date and that the registration workflow is already running smoothly before it.

Insight four: device registration is a pre-market action, not a back-entry after launch.

Article 31 places device registration before placing on the market (custom-made devices and devices for clinical investigation being excepted). From 2026-05-28, placing a device on the market without completed registration is a visible violation at market surveillance level. Because registration data feeds the traceability chain, an unregistered device also weakens every downstream document that references it, from certificates to declarations of conformity, so the registration step should be wired into the product release workflow as a blocking check rather than a parallel task.

4. Practical recommendations

1. Set obtaining the SRN as an early project milestone, ahead of finalising the technical documentation.
2. Maintain an SRN register: entity, role, SRN, registration date, most recent update date and the responsible person.
3. Document the authorised representative’s verification of the manufacturer’s registration (Article 11(3)(c)).
4. Make device registration a mandatory checkpoint before product release; do not ship without it.
5. Retain the submission confirmations and screenshots from EUDAMED as compliance evidence.

5. Verification checklist

Confirm the following items against your own records before the mandatory date and at each audit.

• □ The manufacturer has completed EUDAMED economic operator registration and obtained an SRN (Article 30)
• □ The authorised representative has completed registration and obtained an SRN
• □ The importer has completed registration and obtained an SRN (where applicable)
• □ It is confirmed that distributors are not within the scope of registration
• □ Device registration is complete (Article 31, except for custom-made and investigational devices)
• □ The mandatory use date of the module (2026-05-28) has been confirmed
• □ Registration confirmations and screenshots are archived

Regulatory information verified as of 29 October 2026.

GRZAN helps manufacturers prepare for EUDAMED registration under the EU MDR, providing EU Authorised Representative (AR) and PRRC services, SRN registration support and verification duties under Article 11(3)(c), device registration workflows ahead of the 2026-05-28 mandatory date, and fee and budget planning for notified body conformity assessment. Our team maintains SRN registers, submission evidence files and pre-release checkpoints so that companies without an establishment in the European Union meet their obligations under Regulation (EU) 2017/745. For practical support with registration, traceability and budget matters, contact GRZAN at info@grzanglobal.com.