EUDAMED FAQ: market information, status, EMDN, warnings

By the eudaflow team · Published: 2 October 2026

Which market information EUDAMED requires, which device status to choose, when a language is needed for warnings and what to do when no EMDN code fits.

Four fields of the device record cause most of the questions in the registration work. Each answer names the EUDAMED document it comes from.

Market information: are the dates required and which countries count?

The start and end dates are optional. The country list is not a worldwide distribution list: it holds the EU countries where the device is or will be made available, plus a few special values in the EUDAMED country list, such as XI for Northern Ireland. The country of first placing on the EU market is a separate field.

What the documents say:

Dates: in the data-exchange rule for market information, the start date and the end date are marked optional.
Countries of availability: in the user interface they are mandatory when the status is On the EU market and the device is not MDR Class I or IVDR Class A. You can enter them for all risk classes. The business rules ask for them for MDR and MDD devices of Class IIa, IIb and III and for IVDR devices of Class B, C and D.
Country of first placing: only one country can be set, and it counts automatically as a country where the device is made available. It cannot be changed through a market-information update. To change it, use the UDI-DI update service.
Wrong country codes: a code outside the allowed list is rejected with the rule BR-DTX-UDI-100, "Not a EU country".

If the status is Not intended for the EU market or No longer placed on the EU market, neither the country of first placing nor the countries of availability can be provided.

Sources: UDI Devices business rules, rules 096, 100 and 101 of the data exchange and BR-UDID-043 to -046; UDI Devices user guide, section 3.1.5; Information Centre, additional device information; EUDAMED country list (XSD). Last checked 29 September 2026.

Which device status applies: on the market, no longer, or not intended?

EUDAMED has three statuses: On the EU market, Not intended for the EU market and No longer placed on the EU market. You choose the status when you register the device. A device that is not intended for the EU market may also be registered in EUDAMED.

Changing the status later follows rules:

Not intended for the EU market can only be set as the initial status. A device that started with it can only be updated to On the EU market.
A device that started as On the EU market or No longer placed on the EU market can be switched between those two.
When a device is set to No longer placed on the EU market, EUDAMED creates new versions of its linked container packages with the same status, and the market information is no longer displayed.
Legacy devices have only two statuses: On the EU Market and No Longer placed on the Market.

Sources: UDI Devices user guide, sections 3.1.3 and 5.2.3; UDI Devices business rules, BR-UDID-073 and BR-UDID-458. Last checked 29 September 2026.

When do critical warnings and storage conditions need a language?

When the type is Other. Then EUDAMED requires a description and the language of that description. This applies to storage and handling conditions and to critical warnings or contraindications alike.

Details:

Some predefined types also ask for a description. The rule for those does not mention a language.
The description for Other can be given in several languages.
In the user interface, choosing Other for either field opens a description and a language field.

Sources: UDI Devices business rules, BR-UDID-028 and BR-UDID-030; Information Centre, UDI-DI characteristics. Last checked 29 September 2026.

No EMDN code fits my device. What now?

Use the code extension 99 ("Others") of the matching EMDN type, but only if none of the more specific levels fits the device. Then propose a new term through the EMDN submission platform, or through the MDCG Nomenclature Working Group. Once a new code exists, update your EUDAMED registration and your regulatory documentation.

Points that decide the answer:

Start from the most granular, terminal code. Codes with extension 90 ("Various") are not terminal, and no UDI-DI can be registered with a 90 code.
UDI-DIs with a 99 code get extra scrutiny in the annual EMDN review.
The EMDN changes every year, and the Commission does not notify users one by one. Read each annual publication for changes to your codes.
Obsolete codes stay visible, but they can no longer be used for new registrations or for updates to existing registrations. When you update a device that carries an obsolete code, you need a valid one.

Sources: MDCG 2021-12 Rev.2, questions 6, 9, 13, 14, 17, 27 and 28. Last checked 29 September 2026.

Sources and how we checked

Every statement above is tied to a quote in a claims register, and a script compares each quote with the current text of its source before we publish. The EUDAMED documents here are version 2.27.0 of 2026, and rules and screens can change with each release. This page is general information, not legal advice.