The first EUDAMED deadline has passed. The second has not, and it is the larger job for most catalogs, because it covers everything that was already being sold rather than everything new. If you sell into the European Union and your product data has not been reconciled against what is registered, the six month window is the one that matters now.
The Two Dates, and Why They Are Different
The split exists because registering a device before it goes on sale is a manageable requirement for something new, and an impossible one for a portfolio that has been trading for years. So the Regulation separated the two. New devices get a hard gate at the point of market entry. Devices already circulating got a transition window instead.
The Window Is Not a Grace Period for New Devices
Who Has to Register, and Who Does Not
This is the point most summaries blur, and getting it wrong sends a team chasing an obligation it does not have while missing one it does.
| Role | Registers as an actor? | What it still has to do |
|---|---|---|
| Manufacturer | Yes | Obtains a single registration number and registers its devices in the UDI and device module. |
| Authorised representative | Yes | Registers, and is verified by the manufacturer it represents. |
| Importer | Yes | Registers, and verifies that the manufacturer and the device are registered before importing. |
| System or procedure pack producer | Yes | Registers in the same way as other economic operators. |
| Distributor | No, not under the Regulation itself | Verifies CE marking, the declaration of conformity, labelling and language before making a device available, and cannot lawfully supply an unregistered device. |
That last row is the one worth reading twice. A distributor has no actor registration duty under the Regulation, which is why so many distributors concluded EUDAMED was somebody else's problem. It is not, because the verification duties bite anyway, and because member states are free to maintain or introduce national provisions requiring the registration of distributors operating on their territory. Absence of an EU level duty is not absence of a duty.
What This Means for Catalog Data
EUDAMED is a registration system, not a content system, so nothing here tells you how to write a product page. What it does is turn a set of previously soft data fields into fields with a consequence attached. If your catalog and the registration record disagree about which device a line refers to, one of them is wrong, and the catalog is the one you can fix.
- Reconcile identity first. Every EU line in the catalog needs to resolve to a specific device, not to a family or a marketing name.
- Record the basic UDI-DI and the UDI-DI separately. They answer different questions and a single identifier column cannot hold both.
- Capture the actor behind each line. Knowing which manufacturer or authorised representative stands behind a product is what lets you check its registration at all.
- Flag legacy lines explicitly. The population subject to the November deadline is defined by when the device was placed on the market, which is a fact your catalog probably does not currently store.
- Treat unresolved lines as commercial risk, not as data debt. A line you cannot identify is a line you cannot confirm is registered.
The Reconciliation Nobody Scopes
In practice the work is rarely the registration itself. It is discovering that the catalog holds four thousand lines, that six hundred of them are the same device entered differently, that two hundred refer to products that have not been available for years, and that nobody can say with confidence which manufacturer stands behind a further hundred. None of that is visible until something forces a line by line reconciliation, and a registration deadline is exactly that kind of forcing event.
The useful output of this exercise is not a compliant catalog. It is a list: the lines that resolved cleanly, the lines that resolved to something you did not expect, and the lines that did not resolve at all. The third group is small, and it is where the real exposure sits.
One Thing This Page Is Not