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

As of 2026: actor registration in EUDAMED is already mandatory for all manufacturers. UDI/device registration is mandatory for Class III and Class IIb devices (required since 2023) and for Class IIa and Class I devices (phasing in through 2025–2026). The vigilance module is planned to become mandatory in mid-2026, replacing national reporting for serious incident reports. 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 using your EU Authorised Representative's EU Single Registration Number (SRN) if you are a non-EU manufacturer, (2) Complete actor registration — providing company details, Authorised Representative information, 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

Non-EU manufacturers (including Turkish manufacturers) must have an EU Authorised Representative to register in EUDAMED and to place CE-marked devices on the EU market. 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. Turkish manufacturers without a current EU Authorised Representative cannot legally sell CE-marked devices in the EU market — this is a prerequisite, not an option.

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 current EU Authorised Representative details ☑ 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.