GMDN to EMDN Mapping
If your company already has GMDN codes for your devices, you cannot use them in EUDAMED. The EU requires EMDN, a separate classification system, and there is no official conversion table. You need to re-classify each device from scratch.
GMDN and EMDN are different systems
Both systems classify medical devices, but they were built by different bodies for different purposes. Knowing the structural differences explains why automatic conversion is impossible.
Why the EU introduced EMDN
GMDN was designed as a global nomenclature system and reflects a broad, internationally harmonised classification approach. The European Commission decided that EU regulatory purposes required a more granular, purpose-driven system aligned with the MDR and IVDR risk classification frameworks.
EMDN is deeper and more specific than GMDN. Where a GMDN code represents a generic device type, an EMDN leaf code describes a specific device configuration with a specific intended clinical purpose. This granularity is what allows EUDAMED to be a meaningful regulatory database rather than just a product inventory.
From a practical standpoint, this means that manufacturers who had GMDN codes assigned through their notified body or via FDA 510(k) submissions need to treat EMDN classification as a distinct, standalone step, not a translation exercise.
How to approach the mapping process
The most reliable approach is to use the GMDN code as context, not as a guide. Start from the device description and intended purpose each time.
Pull your GMDN data
Export your current device list with GMDN codes and their associated descriptions. If you have a GMDN code, you also have the Generic Device Group name; this is useful context for the EMDN search.
Write the intended purpose for each device
Do not look at the GMDN code to guide the EMDN search. Instead, write a one-sentence intended purpose statement for each device as it would appear in your device's Instructions for Use (IFU).
Open the EMDN nomenclature browser
The European Commission maintains a public EMDN browser within the EUDAMED portal. Use the free-text search to find candidate codes, then verify by navigating the hierarchy from the top-level letter category down to the leaf node.
Use GMDN as a sanity check, not a map
After finding your EMDN candidate, cross-reference: does the EMDN description match the GMDN Generic Device Group name? If there is a major semantic mismatch, review your EMDN selection before proceeding.
Document the rationale
Record why each EMDN code was selected, not just which code was selected. This justification becomes part of your Registration Decision Record and is the evidence auditors will examine if a code is challenged.
Mapping challenges to watch for
These are the issues that most commonly cause incorrect EMDN assignments during the GMDN migration.
No official mapping table exists
The European Commission has not published a GMDN-to-EMDN crosswalk. There is no official lookup table that converts a GMDN code to its EMDN equivalent. Every device must be classified in EMDN independently.
Granularity mismatch
One GMDN code often maps to multiple EMDN leaf codes. 'Surgical glove' in GMDN might correspond to different EMDN codes depending on material, sterility, and reuse type. You cannot assume a 1:1 correspondence.
Intended purpose divergence
GMDN classifies by generic device type. EMDN classifies by intended purpose. Two devices with the same GMDN code can have different EMDN codes if their clinical applications differ, even if they are physically identical.
IVD handling differences
In vitro diagnostics are treated very differently between the two systems. GMDN has broad IVD categories. EMDN places all IVDs under the 'K' category with highly specific subcodes that also correlate to IVDR risk class.
Working with large portfolios
If you have 50+ devices, manual re-classification is a significant time investment. At scale, the key is to build a classification template: group devices by type and intended purpose, classify one device in each group correctly, then extend the reasoning to the rest. This reduces individual decisions from N to the number of distinct device types in your portfolio.
Manufacturers with complex portfolios often discover during this process that their GMDN codes were inconsistently applied across product lines; EMDN mapping becomes an opportunity to audit and standardise the device classification record.
How EUDAMate handles GMDN-to-EMDN mapping
EUDAMate accepts your existing device data, including GMDN codes and device descriptions, and uses an AI classification engine trained on the full EMDN taxonomy to suggest the correct EMDN code for each device. The GMDN code is used as supplementary context; the primary classification signal is the device description and intended purpose.
Ready to convert your GMDN codes?
Upload your device list and EUDAMate will suggest an EMDN code for each device, with confidence scoring and full documentation for your registration record.
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