EU database · MDR · IVDR · mandatory since 28 May 2026
EUDAMED registration for medical devices and IVDs
Register the legal entity first. Then make every product record agree with the evidence behind it.
EUDAMED is no longer a voluntary preview. The practical challenge is to connect the actor, authorised representative, identifiers, device data and certificates without creating contradictions that surface during validation or market surveillance.
See what is mandatory ↓Legal entity
SRN validatedBasic UDI-DI
UDI-DI
EMDN
Certificate
Consistent · controlled · current
28.05
2026The current position
Four modules are mandatory. Two are still waiting.
Commission Decision (EU) 2025/2371 confirmed that four modules were functional. The six-month transition ended on 28 May 2026, turning them from voluntary systems into the required route for the functions they cover.
Actor registration
Economic-operator identity, competent-authority validation and SRN or Actor ID.
Industry-facingUDI and device registration
Basic UDI-DI, UDI-DI, EMDN and the regulatory data describing each device.
Industry-facingNotified Bodies and certificates
Notified Body decisions, certificates and related certificate information.
Notified Body-facingMarket surveillance
Coordination and exchange of surveillance information between authorities.
Authority-facingVigilance and post-market surveillance
In developmentClinical investigations and performance studies
Under analysisInteractive actor route
The correct registration path begins with the legal role
Select a role to see who validates the request, which identifier is issued and where the critical dependency sits.
Direct actor route
Register the manufacturer before registering its devices
The actor request goes to the competent authority responsible for the manufacturer’s registered place of business. After validation, EUDAMED issues the SRN used in subsequent regulatory transactions.
Single Registration Number
Responsible competent authority
Exact legal-entity data and signed information-security declaration
Approve user access and prepare device master data
Representative-dependent route
The authorised representative is part of the validation chain
The manufacturer first needs an active authorised representative in the Actor module. The request identifies that representative and includes a mandate summary. The representative verifies the submission before competent-authority validation.
Single Registration Number for the manufacturer
Authorised representative, then responsible authority
Active representative and accurate mandate relationship
Keep manufacturer and representative records synchronised
Independent actor route
The importer obtains its own SRN and verifies its supply-chain links
An importer registers as a separate economic operator. It also verifies the manufacturer and, where applicable, authorised-representative information and adds its own details to the relevant record within the regulatory timeframe.
Importer Single Registration Number
Authority responsible for the importer
Correct manufacturer and representative relationship
Control verification and record changes across the portfolio
No ordinary actor route
A distributor does not register in EUDAMED merely because it distributes devices
Distributors are outside ordinary Actor-module registration. They must still meet MDR or IVDR distributor duties and any national registration rules. Relabelling, repackaging or own-brand activity can change the analysis.
No distributor SRN
Not applicable for ordinary distribution
National requirements and actual Article 16 activity
Document role boundaries before changing product presentation
The controlled sequence
Do not begin with data entry. Begin with ownership.
A clean submission depends on decisions made before anyone opens the EUDAMED form.
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01
Governance
Name the Local Actor Administrator
Give one accountable function authority to control the actor record, approve users and coordinate regulatory data owners.
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02
Identity
Freeze the legal-entity record
Align legal name, address, registration identifiers and economic-operator role with contracts, certificates and regulatory documentation.
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03
Actor request
Submit the evidence and declarations
Complete the actor request, upload the signed information-security declaration and include the representative mandate summary where required.
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04
Validation
Resolve authority questions and receive the SRN
The competent authority verifies the request. EUDAMED generates the identifier only after approval.
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05
Access
Approve users by function, not convenience
Every person acting for the organisation requests access. Grant the minimum role needed and remove access promptly when responsibilities change.
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06
Device record
Publish controlled master data
Build the Basic UDI-DI and UDI-DI records from approved sources, verify links and retain evidence of review before submission.
The identifier architecture
One product can carry several identifiers without becoming several products
The most common conceptual error is to treat the SRN, Basic UDI-DI, UDI-DI and UDI-PI as competing labels. Each identifies a different layer.
SRN
Identifies the registered economic operator, not a device.
Basic UDI-DI
Connects devices that share defined purpose, class and essential design characteristics.
UDI-DI
Identifies a device model, version or packaging level according to the UDI rules.
UDI-PI
Carries lot, serial, software-version, manufacture or expiry information as applicable.
EUDAMED device registration is performed at the UDI-DI or applicable device-identifier level. It does not create a separate database record for each serial number, lot or other individual UDI-PI.
Submission readiness
Make the database the output of controlled records
Each EUDAMED field should have an owner and a source. If the public record, Declaration of Conformity, certificate, label and technical documentation describe the device differently, the database has exposed a governance problem rather than created one.
Identity data
Legal manufacturer, authorised representative, importer links and validated actor identifiers.
UDI structure
Issuing entity, Basic UDI-DI, UDI-DI, packaging hierarchy and applicable production identifiers.
Regulatory attributes
Device class, applicable legislation, intended purpose, model, trade name and special characteristics.
Nomenclature
Current EMDN code selected at the right level and supported by the device’s purpose and technology.
Conformity links
Notified Body and certificate references where applicable, aligned with the covered device scope.
Lifecycle status
Market status, dates, changes and discontinuation handled through documented regulatory change control.
Transition timeline
The switch became legal in stages, but the data work should not
Whether a record was due immediately or within a transition depends on what was placed on the market and when.
The six-month clock began
The Commission published the notice confirming that the first four modules were functional.
New actor and device obligations moved into EUDAMED
A device first placed on the market from this date must be registered before the first unit is placed on the market.
Continuing qualifying device records became due
The six-month period ended for relevant Regulation and legacy devices already on the market and still being placed on the market.
Earlier MDR and IVDR certificate records become due
Notified Bodies complete the 18-month transition for certificates issued before mandatory use of the certificate module.
Custom-made devices
The device itself is outside ordinary UDI/Device registration, although its manufacturer may need actor access for other obligations.
Investigational and performance-study devices
They do not follow the commercial UDI/Device registration route. Study processes remain subject to their own legal and transitional channels.
Devices no longer placed on the market
A device that ceased being placed on the market before mandatory use may remain outside registration unless a later post-market or vigilance action requires a record.
After registration
A valid submission can become inaccurate the next morning
Legal names change. Representatives change. Certificates are suspended or replaced. Product configurations and market status evolve. EUDAMED maintenance therefore belongs inside regulatory change control rather than inside one administrator’s inbox.
One approved change should update every affected record, label, declaration, certificate link and EUDAMED field through the same traceable workflow.
Detect
Regulatory, corporate, product or certificate change begins.
Assess
Owners identify affected actor and device records.
Approve
Source evidence and revised data receive controlled review.
Reconcile
EUDAMED and internal records are checked for agreement.
Failure patterns
Most registration defects begin outside EUDAMED
The database usually reveals identity, classification or master-data decisions that were never resolved properly.
A brand is entered as the manufacturer
The legal entity on the actor record does not match the entity carrying MDR or IVDR manufacturer responsibility.
Resolve the legal role before the recordThe SRN is treated as a product identifier
The economic-operator identifier is confused with the Basic UDI-DI or UDI-DI structure.
Map each identifier to its layerCertificates and device scope disagree
Models, classes or Basic UDI-DIs in the device record do not align with the Notified Body certificate.
Reconcile before publicationEMDN selection is delegated without context
A code is chosen by keyword rather than intended purpose, technology and regulatory characteristics.
Document the nomenclature rationaleUser access survives role changes
Former staff or suppliers retain unnecessary permissions while current owners cannot act.
Review access as a controlled recordThe submission becomes the master file
Information is invented in the interface and no approved internal source can later explain it.
Publish from controlled source dataPractical questions
EUDAMED registration FAQ
Open the question that affects your actor request, UDI plan or transition review.
Which EUDAMED modules are mandatory now?+
Since 28 May 2026, the Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance modules have been mandatory. The first three directly support industry registration and conformity workflows. The Market Surveillance module is primarily used by competent authorities and the European Commission. The Vigilance and Post-market Surveillance module and the Clinical Investigations and Performance Studies module are not yet mandatory.
Who must obtain a Single Registration Number?+
Manufacturers, authorised representatives and importers that fall within MDR Article 31 or IVDR Article 28 must register as actors. EUDAMED issues an SRN after the competent authority validates the request. A system or procedure pack producer receives an Actor ID rather than an SRN.
Must distributors register as EUDAMED actors?+
No. Distributors are not required to register in the EUDAMED Actor module. National registration obligations may still apply, and a distributor that assumes manufacturer obligations under MDR or IVDR Article 16 must assess its role separately.
How does a non-EU manufacturer register?+
A non-EU manufacturer needs an active EU authorised representative before submitting its actor request. The request includes information about the representative and a mandate summary. The authorised representative verifies the request before it proceeds to the responsible competent authority for validation.
What is the difference between Basic UDI-DI, UDI-DI and UDI-PI?+
The Basic UDI-DI is the main regulatory identifier for a group of devices sharing defined characteristics. The UDI-DI identifies a specific device model or trade item. The UDI-PI identifies production information such as a lot, serial number, software version or expiry date. EUDAMED device registration is performed at identifier level and does not create a separate device record for every individual UDI-PI.
What was the 28 November 2026 device deadline?+
The transition rules give qualifying Regulation and legacy devices that were already placed on the market before 28 May 2026 and continue to be placed on the market a six-month registration period ending on 28 November 2026. A device first placed on the market on or after 28 May 2026 must be registered before its first unit is placed on the market.
Are custom-made and investigational devices entered in the UDI/Device module?+
No. Custom-made devices, investigational devices and devices for performance studies are excluded from ordinary UDI/Device registration. A custom-made device manufacturer may nevertheless need actor registration when another EUDAMED obligation requires access.
What happens while two EUDAMED modules remain unfinished?+
Economic operators should use the mandatory EUDAMED modules for the functions now covered by them. Vigilance, post-market surveillance, clinical-investigation and performance-study processes continue through the applicable EU transitional and national channels until the corresponding modules become mandatory.
Primary sources
Work from the live rules, not an old implementation slide
EUDAMED implementation is still evolving. Verify Commission notices, current guidance and national requirements before making a time-critical submission.
European Commission EUDAMED overview
Module status and mandatory-use framework
Actor Registration module
Actor request, SRN and user access
UDI and device registration
Device data, EMDN and legacy devices
Commission transition Q&A
Actor, device and certificate obligations
Official transition timeline
Mandatory dates for devices and certificates
Regulation (EU) 2017/745
Articles 29 and 31 and Annex VI
Regulation (EU) 2017/746
Articles 26 and 28 and Annex VI
Build a defensible data chain
Need help preparing or reconciling EUDAMED records?
MDRC can structure actor onboarding, Basic UDI-DI and UDI-DI data, EMDN selection, certificate mapping and the change-control process that keeps submissions aligned with the technical documentation.
