What EMDN Is
The European Medical Device Nomenclature (EMDN) is the classification system mandated by MDR Article 26 and IVDR Article 23 for identifying medical devices registered in EUDAMED. Every device record submitted to EUDAMED must carry exactly one EMDN code. It is the primary language the system uses to identify what a device is, independent of trade name or manufacturer branding.
EMDN was developed by the European Commission working from Italy's CND (Classificazione Nazionale dei Dispositivi medici), a classification system that had been in use in Italy since 2007. The Commission adapted the CND structure and extended it to cover the full EU device portfolio. The first official EMDN release was published in 2021; the current release is v2026.
EMDN is a free-to-usesystem. Neither manufacturers nor Authorised Representatives pay licensing fees to access or use the nomenclature. The full code list and browser are available at the European Commission's EMDN portal. This is a deliberate policy contrast with the GMDN system, which charges for term access.
The 23 Categories
EMDN is organized into 23 top-level categories, each identified by a single capital letter. Each category covers a broad functional domain of medical devices, from administration and collection devices through active implantables to software and Annex XVI products without an intended medical purpose. Note that the letters E, I and O are not used.
| Code | Category Name |
|---|---|
| A | Devices for Administration, Withdrawal and Collection |
| B | Haematology and Haemotransfusion Devices |
| C | Cardiocirculatory System Devices |
| D | Disinfectants, Antiseptics, Sterilising Agents and Detergents for Medical Devices |
| F | Dialysis Devices |
| G | Gastrointestinal Devices |
| H | Suture Devices |
| J | Active-Implantable Devices |
| K | Endotherapy and Electrosurgical Devices |
| L | Reusable Surgical Instruments |
| M | Devices for General and Specialist Dressings |
| N | Nervous and Medullary Systems Devices |
| P | Implantable Prosthetic and Osteosynthesis Devices |
| Q | Dental, Ophthalmologic and ENT Devices |
| R | Respiratory and Anaesthesia Devices |
| S | Sterilisation Devices (excluding Cat. D - Z) |
| T | Patient Protective Equipment and Incontinence Aids (excluding Personal Protective Equipment - PPE) |
| U | Devices for Urogenital System |
| V | Various Medical Devices |
| W | In Vitro Diagnostic Medical Devices |
| X | Products Without an Intended Medical Purpose (Annex XVI) |
| Y | Devices for Persons with Disabilities Not Included in Other Categories |
| Z | Medical Equipment and Related Accessories, Software and Consumables |
Hierarchical Structure
Every EMDN code is a path through a seven-level hierarchy. The levels run from the broad category letter down to a terminal code that identifies a specific device type. Each additional level adds one or more characters to the code string, creating an identifier that gets longer and more specific as it descends.
A real example from category A, running the full seven levels:
A: Devices for Administration, Withdrawal and Collection (Level 1)A02: Syringes (Level 2)A0201: Single-Use Syringes (Level 3)A020102: Infusion and Irrigation Syringes, Single-Use (Level 4)A02010201: Luer Cone, Single-Use (Level 5)A0201020101: 2-Piece Luer Cone, Single-Use (Level 6)A020102010101: 2-Piece with Needle, Single-Use, terminal code (Level 7)
And a shallower branch: implantable single-chamber pacemakers terminate at Level 5: J (Active-Implantable Devices) → J01 → J0101 (Implantable Pacemakers) → J010101 → J01010101, terminal.
Not every branch reaches all seven levels. Some device types are fully specified at level 4 or 5. The key rule is this: only codes without child entries in the EMDN browser are terminal codes. A code that has children in the hierarchy is a category code and cannot be used in a EUDAMED device record.
One code per device
EUDAMED accepts exactly one EMDN code per device record. If a device has multiple intended purposes that span different EMDN branches, the correct approach is to use the code that best describes the primary intended purpose. Devices with legitimately different primary purposes (combination products, system kits) each get their own device record with their own EMDN code.
Finding the Right Code
The EMDN browser is available at the European Commission's EMDN portal. It supports keyword search and hierarchical browsing. The practical workflow for finding a code goes through three stages.
Stage 1: Clinical function first
Start from the device's clinical function, not its trade name. EMDN codes describe function, not form. "Catheter" describes a physical form that appears in multiple categories. "Cardiac catheter for diagnostic use" maps to a specific branch. Begin with the clinical or diagnostic action the device performs.
Stage 2: Select the top-level category
Identify which of the 23 categories the device's primary function falls under. Most devices map to one category clearly. When a device could sit in two categories (e.g., an electromechanical ophthalmic device), choose the category that reflects the most specific function, not the most general one.
Stage 3: Drill to terminal
Navigate down the hierarchy until there are no further child entries. That leaf node is the correct code. If the browser shows the device type you need but lists it as a parent with children, keep going. Submitting a parent code to EUDAMED will pass initial validation but will be flagged during NB review.
What to do when no code fits
EMDN is updated annually. If your device type genuinely has no matching terminal code, the first step is to search at a broader level and confirm no child codes have been added in recent releases. If the gap is confirmed, contact the European Commission EMDN helpdesk. Do not assign a code from an adjacent category to force a match. An incorrect code creates compliance problems downstream during NB conformity review.
EMDN v2026 Changes
The current EMDN release is v2026, published by the European Commission. Each revision carries three categories of change that affect device registrations prepared against an earlier release.
Three kinds of change to check for
Each EMDN revision can introduce three kinds of change that affect existing device records: new terminal codes (a more specific code may now exist for your device than the one you selected), retired codes (codes removed from the current release are no longer valid for new submissions and need a successor), and hierarchy adjustments (a code that was terminal can become a parent node with new, more specific children below it; former-terminal codes must be remapped to the appropriate child).
The Commission publishes the current release and its change documentation on the official EMDN portal. Always verify a specific code's status against the current release rather than against secondary summaries, including this one.
Common Mistakes
| Mistake | Consequence | Fix |
|---|---|---|
| Using a category-level code, not a terminal code | Accepted by EUDAMED at submission; rejected or flagged during NB conformity review | Verify the code has no children in the current EMDN v2026 browser before using it |
| Assigning EMDN by physical form rather than clinical function | Code is technically wrong class; mismatch found when NB cross-checks intended use documentation | Start from the intended clinical function described in the Instructions for Use |
| Using a code from an EMDN version older than v2026 | Code may be retired or now a parent node; creates validation errors in the live system | Re-verify every code against the current EMDN browser before submission |
| Assigning the same code to all devices in a portfolio | Incorrect codes for all devices that differ in function; systematic compliance issue across the registration | Classify each device independently based on its own intended use documentation |
| Selecting the most specific-sounding code without checking scope notes | Code applied to a device outside its scope; creates inconsistency with the clinical data package | Read scope notes attached to each terminal code in the EMDN browser before finalizing |
EMDN code selection is not a filing step at the end of a project. It is a clinical and regulatory judgment that needs to be resolved early, because the code you choose affects NB review scope, post-market surveillance category, and how your device data is queried by competent authorities. Getting it right the first time is worth the time it takes.
Frequently Asked Questions
What is an EMDN code?
The European Medical Device Nomenclature is the classification system mandated by MDR Article 26 and IVDR Article 23 for identifying medical devices registered in EUDAMED. Every device record submitted to EUDAMED must carry exactly one EMDN code. It identifies what a device is, independent of trade name or manufacturer branding.
How many EMDN categories and codes are there?
EMDN is organized into 23 top-level categories, each identified by a single capital letter, with the letters E, I and O unused. The nomenclature runs to seven hierarchical levels and contains 6,773 terminal codes usable for EUDAMED device registration.
What is a terminal EMDN code, and why does it matter?
Only codes without child entries in the EMDN browser are terminal codes. A code that has children is a category code and cannot be used in a EUDAMED device record. Submitting a parent code passes initial validation but is flagged during Notified Body review.
Can one device have more than one EMDN code?
No. EUDAMED accepts exactly one EMDN code per device record. If a device has multiple intended purposes spanning different EMDN branches, use the code that best describes the primary intended purpose. Devices with legitimately different primary purposes each get their own device record with their own code.
Is an EMDN code the same as a risk classification?
No. EMDN describes what a device does, not how risky it is. Risk classification under MDR Annex VIII is a separate exercise carried out in parallel, and the two are independent inputs to the same EUDAMED device record.
Does using EMDN cost anything?
No. EMDN is free to use. Neither manufacturers nor Authorised Representatives pay licensing fees to access or use the nomenclature, which is a deliberate policy contrast with the GMDN system that charges for term access.
What should I do if no EMDN code fits my device?
Search at a broader level first and confirm no child codes have been added in recent releases, since EMDN is updated annually. If the gap is confirmed, contact the European Commission EMDN helpdesk. Do not assign a code from an adjacent category to force a match, as an incorrect code creates compliance problems during Notified Body conformity review.