V92, MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES, a single terminal code directly under category V. Software that runs alongside a specific instrument family (an imaging system, an IVD analyser, an active implant programmer) is coded inside that family's own branch instead, as one of two sibling terminal codes ending in SOFTWARE ACCESSORIES or MEDICAL DEVICE SOFTWARE. Find the instrument family first. Only fall back to V92 once you have confirmed there is not one.This guide assumes you already know how EMDN's hierarchy works. If you do not, read EMDN Classification Codes Explained first: it covers the 23 categories, the seven levels, and the general workflow for reaching a terminal code. This guide covers only the part of that workflow that trips up software specifically, because software does not get a category of its own and the general workflow does not say where to start looking.
Why Software Needs a Second Look
MDR Article 26 and IVDR Article 23require the Commission to make an internationally recognised medical devices nomenclature available free of charge. EMDN is the nomenclature the Commission designated to meet that requirement, and it is what EUDAMED actually uses to identify devices: every EUDAMED device record, software included, must carry exactly one terminal EMDN code, an operational EUDAMED rule rather than a requirement either article states directly. EMDN's structure was built around physical instrument families first: a category letter, then up to six further levels narrowing down to a specific device type. Software sits inside that same structure, as terminal codes attached to the instrument families it runs alongside, not as a category of its own.
That matters because searching the browser for the word "software" returns codes scattered across five categories, with no shared prefix and no single branch to search within. Almost all of them sit in three: Z (equipment such as imaging and radiotherapy systems), W (IVD instruments) and V (the standalone catch-all). A few more sit in J, for the programmers and remote monitoring systems of active implants, and two in Y, for assistive writing and communication software. The three worked examples below cover the three main places.
The Accessory / Device Split
Wherever EMDN gives a physical instrument family a software code at all, it almost always gives it two, sitting side by side as terminal siblings under that instrument's branch:
- a code ending SOFTWARE ACCESSORIES, and
- a code ending MEDICAL DEVICE SOFTWARE (in category W, this one instead ends IVD MEDICAL DEVICE SOFTWARE).
This is a naming pattern in the nomenclature, not a legal test. EMDN itself does not define what separates the two; it just gives you two terminal descriptions to read and a classification judgment to make against your own intended purpose and Instructions for Use. Read both descriptions in the browser before picking either.
Worked Example: Imaging Software
Take software distributed with a computed tomography system. The full path through category Z (Medical Equipment and Related Accessories, Software and Consumables) to the software pair:
| Level | Code | Term |
|---|---|---|
| 1 | Z | Medical Equipment and Related Accessories, Software and Consumables |
| 2 | Z11 | Bioimaging and Radiotherapy Instruments |
| 3 | Z1103 | Diagnostic and Interventional Radiology Instruments |
| 4 | Z110306 | Computed Tomographs (CT) |
| 5 | Z11030682 | Computed Tomographs (CT) - Software Accessories |
| 5 | Z11030692 | Computed Tomographs (CT) - Medical Device Software, terminal |
Both level-5 codes are terminal; neither has children. The same pair structure recurs across most instrument families under Z11: magnetic resonance systems (Z11050182 / Z11050192), digital computed radiography (Z11060282 / Z11060292), and radiotherapy treatment planning instruments (Z11010482 / Z11010492) all follow the identical accessory/device split one level below their own instrument code. If your imaging-adjacent software runs with a named instrument family, look for its pair before assuming none exists.
Worked Example: IVD Software
IVD software lives in category W (In Vitro Diagnostic Medical Devices) and follows the same sibling pattern, with one naming difference: the device-software code carries an explicit "IVD" marker rather than reusing the plain MEDICAL DEVICE SOFTWARE wording used elsewhere. A chemistry analyser's software, traced the same way:
| Level | Code | Term |
|---|---|---|
| 1 | W | In Vitro Diagnostic Medical Devices |
| 2 | W02 | IVD Instruments |
| 3 | W0201 | Chemistry / Immunochemistry Instruments |
| 4 | W020101 | Chemistry Instruments |
| 5 | W02010101 | Chemistry Analysers |
| 6 | W0201010182 | Chemistry Analysers - Software Accessories |
| 6 | W0201010192 | Chemistry Analysers - IVD Medical Device Software, terminal |
Category W has no catch-all equivalent to V92. Every IVD software code sits under a specific analyser or instrument family, chemistry analysers, immunochemistry analysers, haematology analysers, coagulometers, blood gas analysers, urinalysis instruments, and more, each with its own accessory/device pair one level below the instrument code. If your IVD software does not correspond to any analyser family in the current release, that is the "no code fits" case, not a sign that a general IVD software code exists somewhere uncharted.
Worked Example: Standalone SaMD
Software with no dedicated instrument at all, a clinical decision-support tool, a triage or diagnostic algorithm that takes patient data or third-party images as input rather than operating a piece of hardware EMDN already names, does not have an instrument branch to nest under. For that case, category V (Various Medical Devices) carries a single dedicated code:
| Level | Code | Term |
|---|---|---|
| 1 | V | Various Medical Devices |
| 2 | V92 | Medical Device Software - Not Included in Other Classes, terminal |
V92 sits two levels deep and is itself terminal: nothing sits beneath it. It is a single code shared by every standalone software product that reaches this branch, so it says very little about what any given product actually does. Choosing it correctly does not reduce the documentation burden elsewhere; a Notified Body reviewer will still read the intended-purpose statement and technical file regardless of which terminal code the record carries. What V92 buys you is a defensible answer to "which EMDN code" when the honest answer is that no instrument family fits, not a lighter compliance path.
Common Mistakes
| Mistake | Consequence | Fix |
|---|---|---|
| Filing standalone software under a specific instrument's software code when the product does not actually operate that instrument | EMDN code contradicts the technical file and Instructions for Use; flagged on Notified Body review | Reserve instrument software codes for software that runs that specific instrument family; use V92 when none applies |
| Using the plain MEDICAL DEVICE SOFTWARE or SOFTWARE ACCESSORIES wording for an IVD product | Wrong category for an otherwise valid-looking code; inconsistent with the device's actual regulatory category | Confirm category first: W for IVD instrument software (IVD MEDICAL DEVICE SOFTWARE), J for active implant programmer and remote monitoring software, Z for other hardware-linked software, V for standalone software |
| Assuming a catch-all exists for IVD software the way V92 exists for other standalone software | Search stalls because no such code exists in category W | Search by the analyser or instrument family the software works with, not by the word "software" alone |
| Treating the EMDN code choice as if it also settled the software's risk class | Correct EMDN code, but the intended-purpose-based risk classification is still undone | Keep the two exercises separate; EMDN describes what the software is, risk classification under MDR or IVDR Annex VIII is a parallel step |
| Selecting a parent node one level above the software pair instead of the terminal code itself | Accepted by EUDAMED at submission, rejected or flagged during Notified Body review | Verify the chosen code has no children left in the current EMDN browser before using it |
Software classification under EMDN is a search problem before it is a judgment call: most of the difficulty is knowing which of three categories to look in, not deciding between two terminal descriptions once you are there. Start from the instrument the software actually runs alongside, if any, and treat V92 as the answer for the remainder, not the default.
Frequently Asked Questions
What EMDN code should I use for standalone software with no dedicated instrument?
V92, MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES. It sits directly under category V (Various Medical Devices) as a single terminal code with no further children, and it is the only general-purpose software code in the nomenclature. Use it only once you have confirmed the software is not the software half of one of the instrument-linked pairs described above.
Is there an EMDN catch-all code for IVD software, the way V92 works for other software?
No. Category W (In Vitro Diagnostic Medical Devices) has no equivalent of V92. IVD software is nested under whichever analyser or instrument family it runs with, chemistry analysers, haematology analysers, coagulometers, blood gas analysers and the rest each carry their own software pair. If no analyser family matches, that is the same gap covered in the EMDN classification guide's helpdesk process, not a sign that a catch-all exists.
What is the difference between an EMDN code ending "SOFTWARE ACCESSORIES" and one ending "MEDICAL DEVICE SOFTWARE"?
Both are terminal codes that sit beside each other under the same physical instrument in the EMDN tree. The naming itself does not define which applies to your product; that is a classification judgment based on the software's actual intended purpose, not a rule EMDN enforces. Read both terminal descriptions in the browser and pick the one that matches your Instructions for Use before assuming either fits.
Does an EMDN software code tell me the device's risk class?
No. EMDN describes what the software is, not how risky it is. Risk classification is a separate exercise under MDR Annex VIII or IVDR Annex VIII, and the two are not identical: MDR Annex VIII has a classification rule written for software (Rule 11), while IVDR Annex VIII classifies software through its general implementing rules rather than a dedicated software rule. Either way, picking the right EMDN code has no bearing on that outcome.
Can one instrument family have both a software accessory code and a device software code at the same time?
Yes. Every worked example in this guide, computed tomography, chemistry analysers, and the other instrument families that carry software pairs, lists the two as siblings in the same branch. Neither code implies the other is unavailable; they cover two different kinds of software attached to the same hardware.
Where can I browse the EMDN codes for software myself?
The full tree is at eudamate.eu/emdn. Category V holds the standalone catch-all, category W holds IVD instrument software, category Z holds software for other medical equipment such as imaging and radiotherapy systems, and category J holds software for active implant programmers and remote monitoring systems.
My software doesn't fit any instrument family, and V92 also feels wrong. What now?
Confirm first that no matching instrument family exists in the current EMDN release, since EMDN is updated annually and a more specific code may have been added. If that is confirmed and the software genuinely has no independent medical purpose of its own outside V92's scope, contact the European Commission EMDN helpdesk rather than forcing a code that does not describe the product.