EUDAMED: Six Modules, Rolled Out Separately

EUDAMED is the European database on medical devices, the system EU MDR relies on for registration, traceability and transparency. Parts of it are public.

The thing to understand first is that it is six modules, and they did not arrive together. The staggered rollout is why "is EUDAMED mandatory" has no single answer: it depends which module and when you are asking.

The modules

Actor registration. Manufacturers, authorised representatives, importers and system or procedure pack producers. Registering here yields your SRN, the single registration number, which the other modules require. This is the first thing to do and the prerequisite for everything else.

UDI and device registration. The device record, keyed on the Basic UDI-DI, with the UDI-DIs beneath it.

Notified bodies and certificates. Certificates issued, suspended, restricted or withdrawn, entered by the notified body rather than by you.

Clinical investigations and performance studies.

Vigilance and post-market surveillance. Serious incidents, field safety corrective actions, and periodic safety update reports.

Market surveillance. Competent authority activity.

The Basic UDI-DI is the key

This is the concept with no US equivalent, and it is where manufacturers coming from GUDID get stuck.

A Basic UDI-DI identifies a group of devices sharing the same intended purpose, risk class and essential design and manufacturing characteristics. It never appears on a label or a package. It exists to link a device family to its certificate, its clinical evaluation and its technical documentation.

Under it sit the UDI-DIs, which are the model-level identifiers that do appear on labels.

Getting the grouping wrong is expensive later: it determines how certificates and documentation map to your portfolio, and regrouping means re-registering.

Rollout and obligation

Modules went live at different times, and the Commission staged mandatory use per module rather than switching the whole system on. Actor registration and the UDI/device module came first in practice, with the remainder following.

The practical position for a manufacturer: register as an actor and obtain your SRN regardless, because everything downstream depends on it, and treat the remaining modules as arriving on a schedule you should be tracking rather than a distant future problem.

GUDID and EUDAMED are not interchangeable

Different fields, different structure, and the Basic UDI-DI has no US counterpart to copy from. A manufacturer with a complete GUDID record has done none of the EUDAMED work.