European
Compliance Platform
European
Compliance Platform
Step-by-step guide for medical device and IVD manufacturers
Mandatory since 28 May 2026: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. The Vigilance/PMS and Clinical Investigations/Performance Studies modules are not yet mandatory. Devices first placed on the market before 28 May 2026 may qualify for the device-registration transition until 28 November 2026.
EUDAMED is the EU information system for medical devices and IVDs. This guide reflects the Commission's gradual-rollout rules and distinguishes actor validation from UDI/device data submission.
| Entity / Device | What to Register | Mandatory Since |
|---|---|---|
| Non-EU manufacturer | SRN (Single Registration Number) as economic operator | 28 May 2026 |
| EU Authorised Representative (EC REP) | SRN as economic operator + mandate link to manufacturer | 28 May 2026 |
| EU importer | SRN as an importer; distributors do not register in the Actor module solely because they are distributors | 28 May 2026 |
| Medical device — Class I | Basic UDI-DI, device data, self-declaration reference | 28 May 2026* |
| Medical device — Class IIa | Basic UDI-DI, device data, Notified Body certificate link | 28 May 2026* |
| Medical device — Class IIb / III | Basic UDI-DI, UDI-DI, device data and applicable certificate relationship | 28 May 2026* |
| IVD — Class A | Basic UDI-DI and required device data; NB data where Class A sterile applies | 28 May 2026* |
| IVD — Class C / D (NB-assessed) | Full UDI-DI + IVDR certificate link | 28 May 2026* |
*Transition: devices first placed on the market from 28 May 2026 must be registered before placement. Legacy and Regulation devices first placed before that date generally have until 28 November 2026 for UDI/device registration. New MDR/IVDR certificates issued from 28 May 2026 must be registered in EUDAMED; applicable certificates issued before mandatory use generally have until 28 May 2027.
Official sources: European Commission EUDAMED overview, device-registration transition timeline, and certificates and devices transition timeline.
Create an EU Login account for the person submitting the request. Prepare the legal entity details and EUDAMED supporting documents for the relevant actor role. An EORI number is a customs identifier and is not a universal prerequisite for creating an EUDAMED actor account.
Submit the organisation in the correct role: manufacturer, authorised representative, system/procedure pack producer or importer. Distributors are not an Actor-module role solely by virtue of being distributors. The competent authority validates EU actor requests and issues the SRN.
The non-EU manufacturer submits its own actor request. Its EU Authorised Representative then verifies the manufacturer and mandate-related information before the request moves to the responsible competent authority for validation.
Assign the Basic UDI-DI and UDI-DI under the rules of one of the EU-designated issuing entities: GS1, HIBCC, ICCBBA, or IFA GmbH. Prepare the required device data, including the applicable EMDN code, risk class, intended purpose and device characteristics.
Where the conformity-assessment route requires a notified body, make sure the Basic UDI-DI, device scope and certificate information are consistent. The notified body registers certificate information in the NB & Certificates module; the manufacturer maintains the UDI/device record.
Enter or upload the required device dataset and submit it before first placing a new device on the market. Keep the record current when reportable data changes. Do not confuse actor validation by a competent authority with a universal pre-market authority approval of every device record.
Four modules became mandatory on 28 May 2026: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. The Vigilance/PMS and Clinical Investigations/Performance Studies modules are not yet mandatory. Devices first placed on the market before 28 May 2026 may qualify for transition until 28 November 2026.
There is no single EU-wide processing time. Actor registration depends on AR verification for a non-EU manufacturer and validation by the responsible competent authority. Device registration time depends mainly on whether the identifiers, EMDN code, certificate relationships and required data are ready and internally consistent.
An ordinary self-certified Class I MDR device or Class A IVDR device does not require a notified body. If the applicable conformity-assessment route does require one, the UDI/device data must be consistent with the certificate information that the notified body registers in EUDAMED.
The Basic UDI-DI is the main identifier of a device model or family. It links devices with the Declaration of Conformity, technical documentation and certificates. Unlike the UDI-DI, it is not placed on the device label or packaging. It is assigned under the rules of an EU-designated issuing entity.
Ask the EU Authorised Representative to complete its Actor-module registration first. A non-EU manufacturer's actor request must identify a registered AR, which verifies the manufacturer and mandate-related information before competent-authority validation.
Need an EUDAMED-ready EU Authorised Representative?
ECP connects non-EU manufacturers with EU Authorised Representatives. Confirm the provider's Actor-module status, mandate-verification workflow and responsibility for maintaining device data before appointment.