EUDAMED Registration Deadline: 27 November 2026

There is a deadline in European medical device regulation that is not about certificates, not about classification, and not about anything a regulator will argue with you about. It is administrative, it is absolute, and it is six weeks away.

Devices that were already on the EU market before 28 May 2026 must be registered in EUDAMED by 27 November 2026. After that date, a device that is not registered cannot legally be placed on the EU market. There is no grace period and no appeal.

For first aid kit importers and brands, this is the least glamorous compliance topic of the year and one of the most consequential. Most of the industry's attention has gone to classification — which we covered in detail in our EU MDR classification guide — and very little has gone to the database itself. That is backwards. A classification argument can be resolved after the fact. A missed registration date cannot.

Here is what EUDAMED actually requires, who it catches, and what to check this month.

1. What EUDAMED is, and what it plainly is not

EUDAMED is the European Database on Medical Devices, established under Regulation (EU) 2017/745. It is not a certification body and it does not assess anything. It is a registration and transparency system — and since 28 May 2026, four of its modules have been mandatory: Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance.

Three clarifications are worth holding onto, because they are misread constantly and each misreading costs money:

Registration is not approval. Being listed in EUDAMED says nothing about whether a device is safe, effective, or correctly classified. It says that the device and its manufacturer are identified and searchable.

An SRN is not a device registration. The Single Registration Number identifies an economic operator — the manufacturer, the authorised representative, the importer. It is a company-level identifier. Having one does not mean any particular product is registered.

A Notified Body certificate is not a marketing authorisation. It confirms that the Notified Body assessed a quality system or a technical file. The manufacturer still draws up the Declaration of Conformity and affixes the CE mark.

The reason this matters is that EUDAMED is public. Regulators, healthcare professionals, procurement teams and competitors can all look up your record. A record that is missing, incomplete, or inconsistent with the label is visible to everyone who cares to check — which increasingly includes the hospital group or distributor running a supplier audit.

2. Who has to register by 27 November

The 27 November deadline applies to devices that were already placed on the EU market before 28 May 2026 and will continue to be placed on the market after it. It covers:

*Devices under MDR and IVDR, across all classes — including Class I devices that are self-declared and require no Notified Body

*Devices holding a Notified Body certificate issued under MDR

*Devices that were registered with a national competent authority before the mandatory-use date

If a product was permanently withdrawn from the EU market before 28 May 2026, registration is not required — with the exception of vigilance obligations, which do not switch off when a product does.

Anything newly placed on the EU market after 28 May 2026 is on a different rule. That device must be registered before it is placed on the market. There is no transition window. The distinction inside MDR Article 29(1) — that the Basic UDI-DI and the core data elements in Annex VI Part B must be submitted "before placing" — is a legal precondition, not a target date.

For a first aid kit brand with both an established catalogue and new SKUs in development, that means two separate workstreams running at the same time. The established catalogue is the urgent one.

3. The legacy device trap: EUDAMED-DI and EUDAMED-ID

This is the part that catches suppliers out, and it is worth reading slowly.

Legacy devices are devices certified under the old Directives — MDD, AIMDD, IVDD — or devices that needed no certification under those Directives but now require Notified Body involvement under MDR or IVDR, and which meet the transitional conditions in MDR Article 120 and IVDR Article 110.

The problem is structural: a legacy device has no Basic UDI-DI and no UDI-DI, because those identifiers only came into existence with the Regulations. A UDI was never assigned to it.

EUDAMED solves this by allocating substitutes. The system generates an EUDAMED-DI in place of the Basic UDI-DI and an EUDAMED-ID in place of the UDI-DI. The manufacturer selects the "legacy device" registration path in the UDI/Device module, and the system guides the creation of the EUDAMED-DI rather than accepting an issuing agency's identifier.

Two practical consequences follow:

Your technical file may need work before you can register. To register, you need the data elements, not just a product name. If a legacy device's documentation was assembled years ago under Directive requirements, some of the fields EUDAMED asks for may simply never have been formally recorded.

For first aid kits this is more common than it sounds. A kit that has been exported to Europe for a decade, originally certified under the MDD, is exactly the profile of a legacy device. So is a Class I self-declared kit that has sat in a catalogue unchanged since the Directive era.

4. The exemption that does not exist

There is a widely held belief that if a device is already registered with a national competent authority — INFARMED in Portugal, the Italian Ministry of Health, or any other member state body — the EUDAMED obligation is somehow satisfied.

It is not. Legacy device registration in EUDAMED is an obligation independent of Directive-era national registration. An existing national registration does not constitute an exemption. Regardless of what has been filed with a member state authority, the EUDAMED registration must be completed separately.

This matters because the two numbers are genuinely different and both are needed. A device may hold an INFARMED CDM number and a EUDAMED Basic UDI-DI, and a Portuguese tender specification may ask for both. The national number is what a local clinical board recognises; the EUDAMED identifier is what the rest of Europe can verify. Neither replaces the other.

5. Where registrations actually fail

In our experience across export markets, the failures are rarely about the intent to comply. They are about data alignment — the same device described differently in four systems.

The recurring problem areas:

*Actor data drift. Address changes, a new authorised representative, a restructured legal entity — none of which were propagated into the EUDAMED actor record.

*Identifier mismatch. The Basic UDI-DI on the label, the one in the technical file, and the one submitted to EUDAMED disagree. This is common where a packaging revision updated the label but the regulatory record was not refreshed.

*EMDN classification. The European Medical Device Nomenclature code has to be validated, not guessed. A kit is often assigned a code that reflects the container rather than the contents.

*Certificate mapping. The link between device, certificate and Notified Body has to be built deliberately and kept current.

*Ownership ambiguity. Regulatory, quality, IT and communications teams each assume someone else owns the public-facing record.

None of these are dramatic. All of them stop a submission.

Need to confirm what your European customers' authorised representatives will require from us? Send us your target SKU list and we will return the device data, content lists and UDI information in the format their registration process expects.

6. The second clock: notified body timelines from 25 February 2027

EUDAMED is the deadline with a date attached, but a second change landed in October that will reshape how long European approvals take.

Regulation (EU) 2026/977 sets binding procedural requirements on Notified Bodies across MDR and IVDR — the first time the Commission has imposed hard deadlines on the assessment process itself. The headline timelines:

*Application review and contract signature: up to 30 days

*Quality management system audit: up to 120 days

*Technical documentation assessment: up to 90 days

*Decision and certificate issuance, including entry into EUDAMED: up to 20 days

The regulation also caps the number of interruptions a Notified Body may apply, requires published annual reports on median certification times and median fees, and simplifies re-certification so that initial assessments are not repeated wholesale. It enters into force on 25 February 2027.

For importers, the significance is not the paperwork. It is that certification timelines become a planning input rather than a black box. A supplier who can quote a realistic route to a Class IIa certificate under a known timetable is a different supplier from one who says "it depends on the Notified Body."

It is worth noting that the change is not universally welcomed. On 9 October 2026, Team-NB, the association of European Notified Bodies, published a statement supporting the revision's aims while listing four concerns: that reduced proactive verification could shift supervision toward after-the-fact intervention; that Notified Bodies still lack access to EUDAMED data needed to target oversight; that the new "well-established technology" pathway rests on definitions it calls insufficiently precise; and that mandatory fee discounts for SMEs may strain capacity. Whatever the outcome, the direction is toward a more predictable system — and predictability favours suppliers who document properly.

7. What to ask your supplier this month

Six questions, and a supplier who answers all six in writing has done this before:

1.Which devices in this range fall under the 27 November deadline, and which are outside it?

2.Which of them are legacy devices requiring the EUDAMED-DI path?

3.Who holds the actor registration and the SRN, and is the authorised representative information current?

4.Are the Basic UDI-DI, EMDN codes and certificate links consistent across the label, the technical file and EUDAMED?

5.Who is the named accountable owner of the EUDAMED record on the manufacturer's side?

6.What changes for new SKUs placed on the market after 28 May 2026 — and what is the realistic lead time?

If a supplier cannot answer the first two, the conversation should move quickly. November 27 is not a date that can be absorbed by shipping faster.

8. How Kebon supports EU-bound programmes

We are not the party that completes our customers' EUDAMED submissions — that obligation sits with the manufacturer or its authorised representative, and it is not something a supplier can absorb on someone else's behalf. What we control is the quality of the data that flows into it.

In practice that means:

*Device identification data prepared to EUDAMED's required fields, including Basic UDI-DI structure and label artwork that matches it

*Component-level content lists in a format that maps cleanly to EMDN coding rather than reflecting only the outer case

*ISO 13485 quality management documentation, certificate copies and technical file material for the relevant ranges

*Arabic, Spanish, French and German labelling capability built from our multi-language production experience, so required label changes are a production task rather than a project

*A stable product matrix across the categories European buyers assemble 

programmes from: workplace medical first aid kits, MDR & DIN 13157 kits, car emergency rescue kits, advanced wound closure kits and medical consumables for refill programmes

Where a requested configuration would change the classification of an assembled kit — which, as we explained in the classification guide, is the most expensive mistake available in this market — we say so at quotation stage rather than after the order ships.

Facing the 27 November deadline across a European range? Tell us which SKUs are in scope and we will return the device data and content documentation your registered representative needs, with a realistic lead time rather than an optimistic one.

9. Frequently asked questions

Is the EUDAMED deadline 27 or 28 November 2026?

The date is 27 November 2026, set by Commission Decision (EU) 2025/2371. Some summaries cite the 28th; where a date is contested, work to the earlier one.

Does every first aid kit need EUDAMED registration?

Any device that is placed on the EU market under MDR must be registered — including Class I self-declared products. Devices already on the market before 28 May 2026 have until 27 November 2026; devices placed on the market after that date must be registered before they are placed.

Our product is registered in a member state. Is that enough?

No. National registration does not exempt a device from EUDAMED. Both records exist and serve different functions.

We are an importer, not a manufacturer. What is our obligation?

The device registration obligation sits with the manufacturer. Importers, however, have their own actor obligations and, more practically, a commercial interest in verifying that their supplier's registration is complete — because if it is not, the goods cannot legally be placed on the market and the importer holds the inventory.

What happens if we miss 27 November?

A device that is not registered cannot legally be placed on the EU market. There is no transition extension. Treat it as a hard stop.

Does EUDAMED replace the CE mark or the Declaration of Conformity?

No. It is a registration database. CE marking and the Declaration of Conformity remain the manufacturer's statements of compliance; EUDAMED records that the device and operator exist and can be looked up.

What should we do with six weeks left?

Confirm which SKUs are in scope, confirm whether each is a legacy device, reconcile identifiers across label and technical file, and confirm who owns the actor record. Then get the submission in early. The last week of a registration deadline is not the week to discover a data gap.

The short version

EUDAMED has been mandatory since May. The devices that were already on the European market have been given a transition period, and that period ends on 27 November 2026. It is administrative, it is unforgiving, and it is entirely avoidable — provided someone on the supply side has checked.

That is the part of European compliance that never makes headlines and always makes trouble.