Resources

Guides

Reference material on the EUDAMED deadline, EMDN classification, and the data rules that trip manufacturers up most often.

Deadline

The November 2026 EUDAMED Deadline

Who must register by November 27, 2026, what data is required, and what the legacy transition rules actually say.

Classification

EMDN Classification Codes

Navigate the EMDN category taxonomy and find the correct terminal code for each device.

Mapping

GMDN to EMDN Mapping

Why there is no official cross-reference and how to bridge the gap systematically.

UDI

UDI-DI Grouping Rules

The triggers that require a new Device Identifier and how to structure your UDI hierarchy.

UDI

Who Can Assign a UDI-DI? Manufacturer vs. Distributor

MDCG 2026-5: why only the manufacturer can assign a UDI-DI and register a device in EUDAMED, even under a private-label agreement.

Deadline

What Happens If You Miss the November 2026 EUDAMED Deadline

The actual legal mechanism, the Article 94/95 competent authority procedure that follows, and what the May 2026 precedent shows so far.

Legacy

Legacy Device EUDAMED Registration: What Data Is Actually Required

No Basic UDI-DI, no UDI issuing entity: the EUDAMED DI and EUDAMED ID mechanism, field by field, and why the registration deadline is separate from the 2027/2028 sell-off dates.

Validation

Why EUDAMED Device Registrations Get Rejected

EMDN code lifecycle changes and device-data field conflicts, sourced to the official EUDAMED UDI/Devices Business Rules, with the exact rule reference for each cause.

Data Exchange

EUDAMED XML Bulk Upload vs M2M

The EUDAMED Information Centre's own portfolio-size guidance for choosing between the user interface, bulk upload, and M2M, and what each method requires to set up.

Actor Registration

EUDAMED for Non-EU Manufacturers: Why Your AR Must Register First

A non-EU manufacturer's own registration request cannot be completed until its authorised representative already holds an SRN. The order, sourced to the Commission's own process documentation.

Data Prep

EUDAMED Mandatory Fields: What to Prepare Before You Upload

The column headers EUDAMED accepts for Basic UDI-DI and UDI-DI data, by legislation, generated straight from EUDAMate's own field registry.