Compliance Deadline · 28 May 2026
Step-by-Step Guide for Medical Device Manufacturers
Mandatory from 28 May 2026: Commission Decision (EU) 2025/2371, published on 27 November 2025, confirmed that four EUDAMED modules are functional: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. Under the transitional rules of Regulation (EU) 2024/1860, their use became mandatory six months later, on 28 May 2026, under both the MDR and the IVDR. Devices placed on the market from that date must be registered before they are placed on the market; devices already on the market before 28 May 2026 must be registered within 12 months of the Commission notice.
EUDAMED (European Database on Medical Devices) is the EU's central database for economic operator registration, UDI and device data, and certificates. AFINA has registered devices in EUDAMED for real clients — this guide draws on that work as well as on the regulatory text.
| Actor / device | What is registered | Mandatory from |
|---|---|---|
| Manufacturer (EU or non-EU) | Actor registration → SRN, validated by the competent authority (for a non-EU manufacturer, after verification by its EU Authorised Representative) | 28 May 2026 |
| EU Authorised Representative (EC REP) | Actor registration → SRN; verifies the registration requests of the non-EU manufacturers it represents | 28 May 2026 |
| Importer | Actor registration → SRN | 28 May 2026 |
| Distributor | Not registered in EUDAMED | — |
| Medical devices — all classes (MDR) | Basic UDI-DI and UDI-DI data, risk class, EMDN code; for devices that need a Notified Body, the certificate the Notified Body enters in EUDAMED | 28 May 2026* |
| IVDs — all classes (IVDR) | As above; Class A (non-sterile) is self-declared, Class A sterile, B, C and D need a Notified Body certificate | 28 May 2026* |
* Devices already on the market before 28 May 2026: within 12 months of the Commission notice.
Access to EUDAMED uses EU Login. Prepare the company's legal name, address, registration documents and the details of the person responsible for regulatory compliance (PRRC). VAT, EORI and national trade register numbers are entered where the organisation has them — an EORI number is not a prerequisite for EUDAMED.
Submit an actor registration request for your role: manufacturer, authorised representative, importer or system/procedure pack producer (distributors are not registered). The competent authority validates the request and EUDAMED issues the Single Registration Number (SRN): country code, role and nine digits, e.g. BE-MF-000000001.
A non-EU manufacturer's actor registration is linked to its EU Authorised Representative, who verifies the request before it reaches the competent authority of the representative's Member State. Keep the written mandate under Article 11 MDR consistent with the devices you register.
For each device, enter the Basic UDI-DI and the UDI-DI(s) assigned under the rules of a designated issuing entity (GS1, HIBCC, ICCBBA or IFA), together with the device data: name, intended purpose, risk class, EMDN code (the most specific code available), and device characteristics.
For devices that need a Notified Body (MDR Class Is, Im, Ir, IIa, IIb and III; IVDR Class A sterile, B, C and D), the Notified Body enters the certificate in EUDAMED. The certificate must cover the Basic UDI-DI you register.
Device and UDI data are submitted by the manufacturer. Unlike the actor registration, they are not approved by the competent authority, so the manufacturer is responsible for their accuracy. Register each device before placing it on the market and update the data whenever it changes.
Yes. Following Commission Decision (EU) 2025/2371, actor registration, UDI/device registration, notified bodies and certificates, and market surveillance have been mandatory since 28 May 2026, under both the MDR and the IVDR. Devices must be registered before they are placed on the market; devices already on the market before 28 May 2026 must be registered within 12 months of the notice. Before that date, EUDAMED registration was voluntary at EU level.
Actor registration depends on the competent authority's validation and, for non-EU manufacturers, on verification by the EU Authorised Representative. Device registration has no approval step, so the time goes into preparing UDI data, EMDN codes and certificate references. Start several weeks before your planned EU launch.
The registration is made by the manufacturer, not by the Notified Body. But for devices that need a Notified Body, the certificate must be issued — and entered in EUDAMED by the Notified Body — before the device can be placed on the market. Class I devices without a sterile, measuring or reusable surgical aspect (and IVD Class A non-sterile) are registered without a Notified Body.
A Basic UDI-DI is the primary key that identifies a device model in EUDAMED. It represents the device design and intended purpose, independent of packaging, and is assigned under the rules of a designated issuing entity (GS1, HIBCC, ICCBBA or IFA). It appears in EUDAMED, on certificates, in the declaration of conformity and in the technical documentation — not on the label, which carries the UDI-DI and UDI-PI in the UDI carrier.
Contact your EU Authorised Representative immediately and ask whether they have an active EUDAMED SRN. Your own actor registration cannot be verified until they do. If your EC REP is unwilling or unable to register, consider switching to an EC REP that is already registered. AFINA can connect you with EU Authorised Representatives already registered in EUDAMED.
If your EC REP is not yet registered in EUDAMED — act now
AFINA connects non-EU manufacturers with EU Authorised Representatives already registered in EUDAMED. Submit a request and receive structured responses from EAR service providers who can support your EUDAMED registration.
Send us the product details and we will tell you the next compliance step.