MDR · IVDR · Mandatory modules from 28 May 2026
EUDAMED registration for medical devices
Register the correct legal entity in the correct actor role before entering device data. Actor registration and UDI/device registration are connected, but they are not the same regulatory step.
Since 28 May 2026, four EUDAMED modules are mandatory. A defensible registration starts with verified legal-entity data, the correct role, controlled user access and a plan for keeping the record current.
Start with the distinction
An actor record does not register the device
Actor registration identifies and validates an economic operator. It creates the EUDAMED identity needed to use other modules and to perform regulatory actions on behalf of that legal entity.
UDI/device registration is a separate manufacturer obligation. It connects the validated manufacturer to Basic UDI-DI, UDI-DI, EMDN and the applicable MDR or IVDR device data set. Receiving an SRN does not complete that step.
Identify
Confirm the legal entity and every actor role it performs.
Validate
Submit accurate evidence for authority assessment.
Register
Enter the required UDI and device data after actor approval.
Maintain
Control access, update changes and confirm data accuracy.
Actor roles
Register each role performed by the legal entity
EUDAMED registration is role-specific. If the same legal entity acts in more than one capacity, it submits a separate actor registration for each role.
Role 01
Manufacturer
EU and non-EU manufacturers register before placing relevant devices on the Union market. A non-EU manufacturer first needs an active EU authorised representative in EUDAMED.
- Identifier
- Actor ID that also serves as the SRN
- Non-EU route
- Authorised-representative verification before authority validation
Role 02
Authorised representative or importer
Authorised representatives and importers register in their own roles. An importer also links itself to the relevant non-EU manufacturer records after access is established.
- Identifier
- Actor ID that also serves as the SRN
- Separate roles
- A separate registration when one entity performs both functions
Role 03
System or procedure pack producer
The responsible natural or legal person registers to enter the Basic UDI-DI and other data for systems and procedure packs. This role has a distinct identifier outcome.
- Identifier
- Actor ID that is not an SRN
- Device data
- Registration under the applicable MDR data set
Registration route
Move from EU Login to validated actor
The request is not approved simply because the form is submitted. The route depends on the actor role and establishment country, and ends with validation by the responsible national competent authority.
Account, role and legal-entity data
Create or use an EU Login account, check for an existing actor, select the correct role and country, and enter the legal and contact information.
Documents and non-EU mandate
Upload the signed information-security declaration. A non-EU manufacturer also selects its active authorised representative and provides the mandate summary.
Competent-authority assessment
The authority assesses the request. For a non-EU manufacturer, the authorised representative verifies it before the authority of the representative’s country validates it.
Do not combine manufacturer, authorised-representative and importer functions in one actor request. Each role is registered separately and receives its own role-specific EUDAMED identifier.
Registration evidence
Prepare the data before opening the request
Inconsistent legal names, addresses, identifiers or mandate information are common causes of correction requests and delayed validation.
Core legal and regulatory data
Legal name, registered address, contact points, national trade-register information, VAT details where applicable and PRRC information
+Signed declaration on information-security responsibilities in PDF format
Authorised-representative evidence
Active authorised representative selected in EUDAMED and a mandate summary identifying both parties, mandate dates and covered generic device groups
Use controlled legal data
Match the company name and address to corporate records and use consistent transliteration and punctuation across the request and attachments.
Identify the administrator
The person submitting the actor request becomes the first Local Actor Administrator after validation. Select someone who can maintain the record and manage access.
Plan continuity
The Commission recommends at least two Local Actor Administrators, with at least one belonging to the actor rather than relying entirely on subcontractors.
What follows approval
Actor validation opens the next compliance steps
An approved actor record is infrastructure for compliance. The relevant module obligations still have to be completed by the responsible actor.
Identity
Accept the administrator role
The first user accepts the Local Actor Administrator rights and obligations, validates the notification email and establishes controlled access for additional users.
Products
Register UDI and device data
The manufacturer enters the applicable MDR or IVDR device data, including identifiers, nomenclature and other required data elements. This is separate from Actor registration.
Relationships
Verify mandates and importer links
Authorised representatives manage manufacturer mandates, while importers create the appropriate links to non-EU manufacturers.
Certificates
Coordinate notified-body data
Notified bodies register certificate information in the mandatory module. Manufacturer and certificate data must refer to the correct actor and device records.
Lifecycle
Maintain actor and device records
Changes, confirmations, user access, device updates and discontinued relationships must be managed as controlled regulatory data.
Identifier logic
Actor ID and SRN are related but not interchangeable
EUDAMED identifies every registered actor, but only certain actor roles receive an identifier that is also the regulatory Single Registration Number.
| Actor role | Identifier issued | Regulatory meaning |
|---|---|---|
| Manufacturer | Actor ID/SRN | SRN under Article 31 MDR or Article 28 IVDR |
| Authorised representative | Actor ID/SRN | Separate SRN for the authorised-representative role |
| Importer | Actor ID/SRN | Separate SRN for the importer role |
| System or procedure pack producer | Actor ID | Actor identifier that is not an SRN |
| Several roles held by one entity | Separate identifier per role | Each role requires its own actor registration |
Use the identifier associated with the actor role performing the regulatory action. A manufacturer SRN does not replace an importer or authorised- representative registration held by the same legal entity.
Current module status
Four modules are mandatory
The functionality notice was published on 27 November 2025. After the six-month transition period, mandatory use began on 28 May 2026.
Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance are mandatory.
Clinical Investigations and Performance Studies, and Vigilance and Post-Market Surveillance remain under development.
Readiness check
What to confirm before submission
A clean request is easier for the authorised representative and competent authority to verify and reduces avoidable correction cycles.
Correct legal entity
The entity name, registered address and corporate identifiers match authoritative records.
Correct actor role
Manufacturer, authorised representative, importer and producer roles are not combined.
Duplicate check
The organisation has been searched in EUDAMED before a new actor request is started.
Signed declaration
The current information-security declaration is signed and prepared as a readable PDF.
Non-EU mandate
The authorised representative is active and the mandate summary identifies both parties and covered device groups.
PRRC details
The regulatory person information is complete and consistent with the actor’s compliance arrangement.
Administrator continuity
The first LAA and a practical backup arrangement are defined before the request is submitted.
Device-data plan
Basic UDI-DI, UDI-DI, EMDN and the applicable MDR or IVDR data set are prepared for the next module.
Primary sources
Use the current Commission instructions
EUDAMED screens and procedures evolve. Confirm the operational steps against the current Information Centre and the applicable MDR or IVDR provisions.
European Commission EUDAMED overview
Current module status and implementation timeline
Actor registration module
Registration roles, required documents and official guidance
UDI/Device registration module
Device-data requirements, data sets and EMDN resources
EUDAMED Information Centre
Current user guides, technical documentation and Q&A
Regulation (EU) 2017/745
MDR actor and device registration obligations
Regulation (EU) 2017/746
IVDR actor and device registration obligations
In brief
Questions about EUDAMED registration
Which EUDAMED modules are mandatory in 2026?
Since 28 May 2026, the Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance modules are mandatory. The two remaining modules are still under development.
Is an SRN the same as device registration?
No. The SRN identifies the economic operator in a particular actor role. Device registration is a separate submission in the UDI/Device module.
Can a non-EU manufacturer register before its authorised representative?
No. The authorised representative must already be active in EUDAMED so the manufacturer can select it and the representative can verify the registration request.
Does every registered actor receive an SRN?
No. Manufacturers, authorised representatives and importers receive an Actor ID that also serves as the SRN. A system or procedure pack producer receives an Actor ID that is not an SRN.
Must a company register separately for several roles?
Yes. If one legal entity acts, for example, as both manufacturer and importer, it submits a separate actor registration for each role.
How often must actor information be maintained?
Relevant changes must be updated within one week. Data accuracy must be confirmed no later than one year after initial submission and every second year thereafter.
From actor record to device data
Build a registration that remains usable
MDRC can review the actor model, prepare registration evidence, coordinate non-EU manufacturer and authorised-representative steps, and structure the follow-on UDI/device data submission.