From 28 May 2026, the use of the first four modules of the European database on medical devices, EUDAMED, becomes mandatory. This represents a major regulatory change affecting all actors operating on the EU medical device market – manufacturers, importers, authorised representatives, system and procedure pack producers, as well as notified bodies.
EUDAMED is a central database created by the European Union to increase transparency, safety and oversight of medical devices throughout their entire lifecycle.
EUDAMED modules becoming mandatory in May 2026
The obligation applies to four fully functional modules:
- Actor Registration – registration of manufacturers, importers, authorised representatives, and system/procedure pack producers.
- UDI/Devices Registration – registration of medical devices and their UDI identifiers.
- Notified Bodies & Certificates – upload and management of certificates issued by notified bodies.
- Market Surveillance – module used by market surveillance authorities.
These modules are already technically functional, and a six‑month transition period has been running since November 2025. After it ends, their use becomes mandatory.
Obligations arising for our clients:
1. Actor Registration: Every manufacturer, importer or authorised representative must be registered in EUDAMED and obtain an SRN – Single Registration Number. Without an SRN, no further actions in the database will be possible.
2. Device Registration: Every device must be registered in the UDI/Devices module.
3. Certificate registration: The registration of certificates issued by a notified body falls under the responsibility of the notified body itself. It is conditioned upon the manufacturer’s registration of related medical device. Successful registration of the certificate occurs when data regarding the medical device itself on the manufacturer’s side is linked to data regarding the relevant certificate issued for the medical device on the notified body’s side.
4. Market Surveillance Obligations: Economic operators must cooperate with market surveillance authorities and ensure that device data is accurate, complete and compliant with MDR/IVDR requirements.
Why EUDAMED matters
- increases transparency of information about medical devices,
- improves traceability and monitoring of devices,
- enhances patient and user safety,
- harmonises processes across EU Member States.
Placing devices on the market: difference between “legacy” and “new” devices
- Devices certified before EUDAMED becomes mandatory
(before 28 May 2026)
These devices may remain on the market after 28 May 2026, but the manufacturer must:
- register them retrospectively in EUDAMED,
- assign UDI-DI if not yet assigned,
- ensure that all certificates are uploaded in the Notified Bodies & Certificates module.
In other words: Devices placed on the market before May 2026 remain valid, but must be added to EUDAMED retrospectively.
- Devices placed on the market after EUDAMED becomes mandatory
(from 28 May 2026)
For these devices, the following applies:
- the manufacturer must have an SRN before placing the device on the market,
- the device must be registered in EUDAMED prior to being placed on the market,
- UDI must be assigned and included on the label and packaging,
- the certificate (for applicable device classes) must be uploaded in EUDAMED.
Therefore: After 28 May 2026, no device may be placed on the EU market without prior registration in EUDAMED.
How this changes practice for manufacturers
- The transition period ends on 28 May 2026 — from this date, EUDAMED becomes a mandatory tool.
- Manufacturers must have internal processes in place for UDI management, device registration and data updates.
- Legacy devices must be added to the database; new devices must be registered before being placed on the market.
- Obligations also apply to importers and authorised representatives, who must be registered and linked to the manufacturer.
Useful official links for working with EUDAMED
EUDAMED Main Portal (official entry point)
MDR-Eudamed – Welcome to EUDAMED – European Database on Medical Devices
Central access point to all EUDAMED modules, general information and system overview.
Overview of Modules and MDR/IVDR Requirements
Detailed descriptions of the Actor Registration, UDI/Devices, Certificates and other modules.
User Guides, Manuals and Templates
Official technical guides, onboarding documents, templates for economic operators, UDI registration instructions and more.
EUDAMED Information Centre
Welcome to the EUDAMED information centre
Contact: SANTE-EUDAMED-SUPPORT@ec.europa.eu
Latest updates, system release notes and technical announcements.
Contact: SANTE-EUDAMED-SUPPORT@ec.europa.eu
Eudamed support contact in 3EC International a. s.: eva.rydlova@3ec.sk
* Registration of initially issued certificates and change of Certificates after May 28, 2026 will be invoiced according to pricelist available at www.3ec.sk.