What is EUDAMED and What Does it Do?

EUDAMED is a pan-European database accessible at eudamed.ec.europa.eu that serves as the central registry for: actor registration (manufacturers, authorised representatives, importers, distributors), device registration and UDI data, Notified Body certificates, clinical investigations, post-market surveillance and vigilance data, and market surveillance information. When fully operational, EUDAMED will be the single source of truth for all CE-marked medical devices in the EU and the primary interface between manufacturers and EU regulatory authorities.

The Six Modules of EUDAMED

EUDAMED is structured around six modules that are being activated progressively: (1) Actor Registration — already operational and mandatory for manufacturers registering new devices, (2) UDI/Device Registration — mandatory for all CE-marked device UDI submissions, (3) Notified Bodies and Certificates — operational for certificate management, (4) Clinical Investigations — tracks EU clinical investigation applications and results, (5) Post-Market Surveillance — will capture PMCF summaries and annual safety update reports, (6) Vigilance — will replace the current national-level serious incident reporting with a single EU platform.

Current Mandatory Status and 2026 Timeline

Commission Decision (EU) 2025/2371, published in November 2025, confirmed four modules as functional — actor registration, UDI/device registration, notified bodies and certificates, and market surveillance — and their use becomes mandatory on 28 May 2026. The vigilance module is not among them: it becomes mandatory later, once the Commission confirms it is functional, and until then serious incidents are reported to the national authorities. Manufacturers who are not yet registered as actors in EUDAMED and have not submitted device UDI data are already non-compliant with MDR requirements.

Step-by-Step: How to Register in EUDAMED

Registration in EUDAMED involves the following steps: (1) Create an EUDAMED actor account at eudamed.ec.europa.eu — a manufacturer established in Türkiye registers in its own name, while other non-EU manufacturers use their EU Authorised Representative's Single Registration Number (SRN), (2) Complete actor registration — providing company details, Authorised Representative information where one is required, and EORI number (for customs identification), (3) Once actor registration is approved, access the UDI/device module, (4) Enter UDI-DI data for each device model: basic UDI-DI, device name, classification, intended purpose, and device characteristics, (5) Upload or link relevant certificates (Notified Body certificates for Class I+ devices), (6) Assign UDI-PI ranges to production lots.

Authorised Representative Requirements

Manufacturers outside the EU must normally have an EU Authorised Representative to register in EUDAMED and to place CE-marked devices on the EU market. Manufacturers established in Türkiye are the exception: under the EU–Türkiye Customs Union they have no obligation to designate an authorised representative in the EU, as the Turkish authority TİTCK confirmed in its notice of 19 September 2023. The Authorised Representative must be established in an EU Member State and must be formally designated in writing by the manufacturer. The AR registers the manufacturer as an actor in EUDAMED and is co-responsible for MDR compliance. For manufacturers based in other non-EU countries this is a prerequisite, not an option; a Turkish manufacturer may still appoint a representative by choice, for example to have a contact point in a particular member state.

Post-Market Surveillance Submissions via EUDAMED

Once the PMS module is mandatory, manufacturers must submit Post-Market Surveillance Reports (PMSR) for Class I devices and Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices directly into EUDAMED. PSURs for Class III and implantable Class IIb devices must be submitted annually. These documents will become publicly accessible in EUDAMED — a significant transparency change from the current situation where PSURs are only reviewed by Notified Bodies. Manufacturers should ensure their PSUR content is accurate and professionally prepared.

EUDAMED Readiness Checklist

Complete before May 2026: ☑ Actor registration completed in EUDAMED (with EU Authorised Representative details where one is appointed) ☑ SRN (Single Registration Number) obtained and recorded ☑ UDI-DI data submitted for all Class III, IIb, and IIa devices ☑ UDI-DI submission in progress for Class I devices ☑ Notified Body certificates linked in EUDAMED ☑ PSUR template prepared and internal process for annual submission established ☑ Vigilance reporting process prepared for transition to EUDAMED vigilance module ☑ Staff trained on EUDAMED interface and submission processes

Conclusion

EUDAMED is not just an administrative system — it is the infrastructure of EU MDR compliance. Turkish manufacturers who complete actor registration, submit UDI data, and prepare for the mandatory PMS and vigilance modules will not only be compliant but will have a significantly better-organised regulatory infrastructure overall. The sooner manufacturers engage with EUDAMED, the smoother the transition to mandatory use will be.