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, extended it to cover the full EU device portfolio, and aligned the hierarchy with the IEC 62366-1 intended-use framework. The first official EMDN release was published in 2021. Version 3 was deployed in January 2026.
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 22 Categories
EMDN is organized into 22 top-level categories, each identified by a single capital letter. Each category covers a broad functional domain of medical devices. The full set covers everything from active implantable devices to software to personal protective equipment that falls under MDR scope.
| Code | Category Name |
|---|---|
| A | Active Implantable Devices |
| B | Anaesthesia and Respiratory Devices |
| C | Dental Devices |
| D | Electromechanical Medical Equipment |
| E | Hospital Hardware |
| F | Non-Active Implants |
| G | Ophthalmic and Optical Devices |
| H | Reusable Surgical Instruments |
| I | In Vitro Diagnostic Devices |
| J | Endoscopy Devices |
| K | Contraceptive and Feminine Hygiene Devices |
| L | Laboratory Equipment for IVD Use |
| M | Microbiology and Immunology Devices |
| N | Neurology Devices |
| P | Physical Medicine Devices |
| Q | Radiology Devices |
| R | Single-Use Non-Sterile Devices |
| S | Single-Use Sterile Devices |
| T | Wound Management Devices |
| U | Orthopaedic and Trauma Devices |
| V | Cardiovascular Devices |
| Z | Software and Digital Health Devices |
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 a dot-separated identifier that gets longer and more specific as it descends.
A simplified example for a cardiovascular device:
V— Cardiovascular Devices (Level 1)V01— Cardiac and Vascular Devices (Level 2)V0102— Cardiac Devices (Level 3)V010201— Pacemakers (Level 4)V01020103— Permanent Pacemakers (Level 5)V0102010301— Permanent Pacemakers, Single Chamber (Level 6)V010201030101— Terminal code at Level 7
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 22 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 v3 Changes
EMDN version 3 was deployed in January 2026 alongside the EUDAMED mandatory rollout. The release carried three categories of changes that affect device registrations prepared before that date.
New terminal codes
Category Z (Software and Digital Health Devices) was substantially expanded in v3 to cover Software as a Medical Device (SaMD) types that were previously mapped into adjacent categories or left without a clear terminal code. If your software-based device was previously using a code from Category D or N as a workaround, a direct Z-category terminal code likely now exists.
Retired codes
A number of terminal codes were retired in v3, primarily in Category I (IVD) and Category L (Laboratory Equipment). Retired codes remain queryable in the browser for historical reference, but they are marked as invalid for new submissions. Device records using a retired code must be updated to the successor code before the next review cycle.
Hierarchy adjustments
Several branches in Categories F, H, and S were restructured to add specificity at level 5 and 6. Codes that were previously terminal nodes became parent nodes, with new terminal children added below them. Any device using one of these former-terminal codes must now be mapped to the appropriate new child code.
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 v3 EMDN 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 a pre-v3 EMDN version | Code may be retired or now a parent node; creates validation errors in the live system | Re-verify all codes against the current EMDN browser, especially in categories I, L, F, H, S, Z |
| 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.