EMDN Code: How to Choose the Right One for Your Device

The EMDN code is how EUDAMED knows what your device is. It is not a classification of risk, it does not determine your conformity assessment route, and it does not change your obligations. What it does is describe the device type — and that description is what lets competent authorities, procurement bodies and researchers find devices like yours.

What an EMDN code is

EMDN stands for European Medical Device Nomenclature. It is the nomenclature the Commission has made available for use in EUDAMED, in line with the requirement in Article 26 of Regulation (EU) 2017/745 and Article 23 of Regulation (EU) 2017/746 for a device nomenclature to support the functioning of the European database.

The nomenclature is published by the European Commission and updated periodically. Working from the current published version rather than an internal spreadsheet copied two years ago matters, because codes are added, revised and occasionally retired between versions.

How an EMDN code is structured

The nomenclature is hierarchical. The first level is a broad category identified by a letter. Below the category sit groups, and below the groups sit types. The code lengthens as the description narrows.

This means an EMDN code carries its own context. The beginning of the code tells a reader which family the device belongs to; the end tells them the specific type. Two devices sharing the first characters of their code are related even if their full codes differ.

It also means the hierarchy itself is a decision. You are not only choosing a code — you are choosing how far down the tree to go.

Choosing an EMDN code at the right level

The common failure is not selecting an obviously wrong EMDN code. It is selecting a code at the wrong level of the hierarchy, and the two errors have different consequences.

A code that is too general describes a family rather than your device. The record is accurate and useless: nobody searching for your device type will find it, and procurement systems that filter by code will not surface it. This is a commercial loss rather than a regulatory finding.

A code that is too specific claims characteristics your device may not have. Where the intended purpose in your technical documentation does not support the code you have entered, the mismatch is a finding rather than a preference — and it is a finding that appears in a public database.

The test is straightforward. The EMDN code must be supported by the intended purpose as written in your technical documentation. Not by what the device could plausibly be used for, and not by what the sales literature claims.

Where your EMDN code appears

EMDN codes are entered against Basic UDI-DI and UDI-DI records in EUDAMED. They also appear in Turkish ÜTS registrations, and they are frequently requested in tender documentation across the European Union.

A code chosen carelessly at registration therefore follows the device through every downstream system that reads from these databases. Correcting it later means correcting it in several places, and in some of those places the correction is visible.

A practical approach to EMDN code selection

Group your devices by intended purpose before opening the nomenclature, not after. Devices that share a Basic UDI-DI will usually share an EMDN code — if the codes you arrive at differ significantly within one Basic UDI-DI, that is a signal the grouping itself may be wrong.

Work from the intended purpose statement in the technical documentation, not from the catalogue description. The two are written for different audiences and they often diverge.

Record the reasoning behind each selection. When an EMDN code is questioned two or three years later, the person answering the question will not be the person who chose it, and “it seemed right at the time” is not a defensible answer.

Choosing an EMDN code at the right level of specificity, compared with too general and too specific

Where the EMDN code list is published

The nomenclature is published by the European Commission on its EMDN platform, where the full list can be downloaded as a spreadsheet and individual terms can be searched. The Commission states that "The entirety of the EMDN is accessible to all stakeholders, free of charge." There is no licence to buy and no annual subscription to maintain, which is one of the practical differences between the European nomenclature and the systems some manufacturers were using before.

Two consequences follow for a regulatory file. First, any list held internally is a snapshot: "a new version of the EMDN is released at the end of each calendar year." A code selected from a copy made three years ago may since have been revised or retired, and a EUDAMED record built on it will not match the current version. Second, the nomenclature is not fixed by the Commission alone. Proposals to add or amend terms are submitted through the same platform, with an annual cut-off of 31 January, so a manufacturer that cannot find an accurate term for a genuinely new device type has a route to request one rather than forcing the device into an approximate code.

CND and EMDN: where the codes came from

A search for a CND code list usually ends at the European nomenclature, and the reason is historical. The CND is the Classificazione Nazionale Dispositivi medici, the Italian Ministry of Health's national device classification, and it is the direct ancestor of the European system. The Commission's own account is that "the EMDN was founded following a European Commission notice indicating the utilisation of the Italian Ministry's 'Classificazione Nazionale Dispositivi medici (CND)' as the basis for the future EMDN."

For a manufacturer outside the EU this has a specific practical effect. If an Italian distributor, an Italian public tender or a legacy product file refers to a CND code, the structure will look familiar because the European codes inherited it: the same letter-led category, the same widening levels of detail. That familiarity is not interchangeability. The nomenclature field in EUDAMED expects an EMDN code taken from the current published version, and a CND code copied from an older Italian catalogue is not a substitute for it. Where the two differ, the published EMDN version governs the EUDAMED entry.

How deep the hierarchy goes

The Commission describes the nomenclature as "characterised by its alphanumeric structure that is established in a seven-level hierarchical tree." Three of those levels are named: categories at the first level, groups at the second, and types at the third, with the type level expanding into further levels of detail where the description requires it. A code runs to a maximum of thirteen characters.

Depth is a drafting decision, not a compliance obligation in itself. A code that stops at the group level is defensible when the group genuinely describes the device; a code driven to the deepest available type when the distinguishing feature does not apply to your device is a misdescription, and it is the kind of inconsistency an authorised representative is expected to catch before the record is submitted rather than after a competent authority queries it.

Sources

European Commission — European Medical Device Nomenclature (EMDN), current published version

Regulation (EU) 2017/745, Article 26 — nomenclature for medical devices

Regulation (EU) 2017/746, Article 23 — nomenclature for in vitro diagnostic medical devices

European Commission — EUDAMED UDI/Device registration guidance

Regulation (EU) 2017/745, Annex VI Part B — data elements for device registration

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550. We file EMDN codes against our own device records before we file them for anyone else. We are not a law firm and do not provide legal advice.

Medex files EUDAMED device registrations and Turkish ÜTS registrations for manufacturers outside the Union, and the EMDN code is chosen once and used consistently across both.