What goes mandatory on 28 May
The European Commission has confirmed 28 May 2026 as the date on which the EUDAMED Actor, UDI/Devices and Notified-Body modules transition from voluntary to mandatory use. For a manufacturer of Class IIa medical devices placed on the EU market, that means a registered Single Registration Number on file and Basic UDI-DIs submitted for every commercial product before the deadline.
The Clinical Investigation/Performance Study and Vigilance modules remain on a later timeline. This post covers only the three modules entering force on 28 May.
Modules in scope
Three modules become legally required: Actor registration (manufacturers, importers, authorised representatives, system/procedure-pack producers), UDI/Devices (every device on the EU market identified by Basic UDI-DI and UDI-DI), and Notified-Body certificates (uploaded by the NB and linked to your device records).
Grace period for existing devices
Devices already lawfully placed on the market before 26 May 2025 fall under Article 123(3)(f) of the MDR. Implementation guidance gives a 24-month grace window for registering legacy devices, but registration of the actor is required from 28 May 2026 regardless of legacy status.
Who must register and in what order
The order matters. An actor record creates the SRN; without an SRN, you cannot submit device data. The sequence is: (1) actor request submitted to the competent authority of the member state where your registered place of business is located, (2) competent authority approves and SRN issued, (3) actor submits Basic UDI-DI records, (4) UDI-DI records linked under each Basic UDI-DI.
EUDAMED is sequenced, not parallel. You cannot rush the SRN gate by working on UDIs first; without an approved actor record nothing else accepts.
Sequencing note in the MDCG 2024-3 guidance
Actor registration: the SRN gate
Submit the actor request through the EUDAMED public-facing portal. Mandatory fields include legal name, registered address, the name and contact of the regulatory compliance person (PRRC for in-scope manufacturers), and a declaration of the actor role. The competent authority has a target review window of 30 calendar days; expect 14 to 60 days in practice.
Once approved, the SRN is in the form {member-state}-{actor-type}-{sequence}, for example NL-MF-000123456.
Device registration: Basic UDI-DI first
Basic UDI-DI identifies a device model family. UDI-DI identifies the unit of trade (the specific configuration that gets placed on the market). You submit Basic UDI-DI first; UDI-DI records hang off the Basic UDI-DI as children.
Bulk upload accepts XML matching the EUDAMED XSD. A typical bulk file structure:
<DeviceRegistration>
<BasicUDIDI>
<Code>0470001234567A1</Code>
<ManufacturerSRN>NL-MF-000123456</ManufacturerSRN>
<DeviceClass>IIa</DeviceClass>
<UDIDI>
<Code>04700012345678</Code>
<Status>OnMarket</Status>
</UDIDI>
</BasicUDIDI>
</DeviceRegistration>Common rejection causes
- SRN cited in the file does not match the actor submitting the upload.
- Device class field uses national-language abbreviations rather than the EUDAMED enumeration.
- CND nomenclature code is missing or uses a deprecated revision.
- Basic UDI-DI checksum digit does not validate against the GS1 algorithm.
Notified-Body submissions
Notified-Body certificates are uploaded by the NB, not by the manufacturer. The link from a certificate to a Basic UDI-DI happens on the NB side, but the manufacturer must verify the link appears correctly on the device record after upload.
What to file the morning after
On 29 May 2026, expect to be able to demonstrate: an active SRN, Basic UDI-DI submissions covering every product line on the EU market, UDI-DI records under each Basic UDI-DI, and NB certificate links visible on the device record where applicable.