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The EMDN (European Medical Device Nomenclature) is the code system the European Commission and EU regulators use to classify medical devices in EUDAMED, the European database on medical devices. Each EMDN code begins with a letter, continues with two digits and then a series of digits, with a maximum of 13 digits. It is a different thing from a GMDN code (kept by the GMDN Agency) and from an FDA product code (a three-letter code assigned by FDA). This page is general reference, not regulatory or medical advice.
Short answer
EMDN is a free, regulator-led, hierarchical nomenclature. Manufacturers use it to register devices in EUDAMED, where the code is associated with each device’s UDI-DI. GMDN is a separate nomenclature maintained by the GMDN Agency. An FDA product code is a third, unrelated scheme that FDA uses to identify and track device types in the United States. None of the three tells you a device’s safety, quality or approval status.
What is EMDN?
According to the EU UDI Helpdesk (page dated 19 May 2026, checked 31 October 2026), Article 26 of Regulation (EU) 2017/745 (MDR) and Article 23 of Regulation (EU) 2017/746 (IVDR) set up the EMDN to support the functioning of EUDAMED. Manufacturers use it to register devices there, and the code is associated with each Unique Device Identifier – Device Identifier (UDI-DI).
The Helpdesk also says the EMDN plays a role in technical documentation, the sampling of technical documentation by notified bodies, post-market surveillance and vigilance.
Where it came from
The EMDN is based on the Italian Ministry’s national classification of medical devices (Classificazione Nazionale Dispositivi medici, CND). The CND was already used in Italy, Greece and Portugal. A first version of the EMDN was released on 4 May 2021 (MDCG 2021-12, FAQ on the EMDN, version 1.1, May 2021).
Who can use it
The whole EMDN is accessible to all stakeholders free of charge and can be downloaded in PDF and Excel formats. The Helpdesk names manufacturers, patients, research organisations, practitioners, hospitals and pharmacies among the possible users.
How an EMDN code is structured
The EMDN has a seven-level hierarchical tree grouped into three main levels (EU UDI Helpdesk; MDCG 2021-12):
- Category: the first level, shown as a letter.
- Group: the second level, shown as two digits after the letter.
- Type: the third level, a series of digits that can expand into up to five further levels of detail where needed.
The maximum is 13 digits. MDCG 2021-12 says new terms for medical device software, under Categories J, W and Z, were to be rolled out in the second release. The rule for users is to assign the most granular, terminal term available in the tree, meaning the lowest level that fits the device.
EMDN vs GMDN?
The two are separate nomenclatures run by different bodies. The GMDN Agency describes itself as responsible for the Global Medical Device Nomenclature (GMDN), which is used to name and group medical devices (gmdnagency.org, checked 31 October 2026). The EMDN was founded under criteria set by the European Commission and EU regulators in the Medical Device Coordination Group, with regulators playing the key role in managing and updating it, and it is the one the EU Helpdesk ties to registration in EUDAMED.
GMDN codes appear in the US as well. The FDA states that AccessGUDID includes a GMDN code field with the code’s status (active or obsolete), and that FDA is removing its own Preferred Term codes from GUDID because anyone can now access and use GMDN codes for free (FDA GUDID page, update of 17 December 2024, checked 31 October 2026). A single device can therefore carry an EMDN code in an EU registration and a GMDN code in a US record, and the two should not be assumed to map one to one.
EMDN vs FDA product codes
FDA’s guidance on classification product codes (April 2013) calls them “a method of internally classifying and tracking medical devices”. A CDRH product code is a three-letter combination that associates a device type with a product classification. FDA uses them in premarket review, post-market review, medical device reports, import entry, recalls, and registration and listing. The guidance is non-binding. FDA’s panels in 21 CFR Parts 862-892 are the basis of the product code structure.
| Feature | EMDN | FDA product code |
|---|---|---|
| Who maintains it | European Commission and EU regulators (MDCG) | FDA (CDRH assigns the codes) |
| Format | Letter, two digits, then Type digits; maximum of 13 digits | Three-letter combination |
| Tied to | The UDI-DI in the EUDAMED registration | A device type and its product classification |
| Named uses | EUDAMED registration, technical documentation, notified-body sampling, post-market surveillance, vigilance | Premarket and post-market review, reports, import entry, recalls, registration and listing |
| Cost to use | Free to all stakeholders | Not stated in the guidance |
Source: EU UDI Helpdesk EMDN page and MDCG 2021-12; FDA Medical Device Classification Product Codes guidance. Checked 31 October 2026.
Where it matters for labs, clinics and supply decisions
- Reading a catalogue or registration record. If a listing shows a code starting with a letter and two digits, it is an EMDN-style code. A three-letter code is an FDA product code. Check which system the field belongs to before comparing devices.
- Finding a code. The EMDN is published free in PDF and Excel. For US devices, FDA’s Product Classification Database is the lookup for product codes, and AccessGUDID shows the GMDN term and code on a device record.
- Depth of the code. MDCG 2021-12 says the lowest available level in the tree should be assigned, so the most specific code for a device sits at the end of its branch.
- Examples on CASRAI. The arm trough guide cites an AccessGUDID record that lists the FDA product code IML. Other device explainers include the dental mouth prop and cast tape.
Common misunderstandings
- “The code shows the device’s risk class or approval.” No source describes it that way. The EMDN supports registration, documentation and vigilance. FDA describes product codes as a means of internally classifying and tracking devices, tied to but separate from the classification regulation (see FDA De Novo classification and the Medical Device Amendments of 1976 for the US classification background).
- “FDA product codes are only for submissions.” FDA’s guidance lists uses across the product life cycle, including Medical Device Reporting, import entry and recalls.
- “EMDN, GMDN and FDA codes are interchangeable.” They have different owners, formats and uses, as shown above.
- “MDCG 2021-12 is law.” The document states that MDCG guidance is not legally binding and is not an official Commission position; only the Court of Justice of the European Union can give a binding interpretation of EU law.
FAQ
What is EMDN?
The European Medical Device Nomenclature, a free hierarchical code system created under MDR Article 26 and IVDR Article 23 to support EUDAMED. Manufacturers use it to register devices, with the code associated to each UDI-DI.
EMDN vs GMDN?
They are separate nomenclatures. EMDN is regulator-led and tied by the EU Helpdesk to EUDAMED registration. GMDN is maintained by the GMDN Agency and appears in the FDA’s AccessGUDID. Do not assume a one-to-one mapping.
How long is an EMDN code?
It starts with a letter for the Category, followed by two digits for the Group and further digits for the Type, with a maximum of 13 digits.
Is the EMDN free to use?
Yes. The EU UDI Helpdesk and MDCG 2021-12 both state it is accessible to all stakeholders free of charge.
Sources
- EU UDI Helpdesk, EMDN codes: webgate.ec.europa.eu/udi-helpdesk (checked 31 October 2026).
- MDCG 2021-12, FAQ on the European Medical Device Nomenclature (EMDN), version 1.1, May 2021, copy of the European Commission document (checked 31 October 2026).
- FDA, Medical Device Classification Product Codes: Guidance for Industry and FDA Staff (final, 11 April 2013), fda.gov (checked 31 October 2026).
- FDA, Global Unique Device Identification Database (GUDID), fda.gov (update of 17 December 2024; checked 31 October 2026).
- GMDN Agency, gmdnagency.org (checked 31 October 2026).
