No EMDN Code Fits Your Device: What to Do

This guide assumes you already know how to navigate EMDN's hierarchy. If you do not, read EMDN Classification Codes Explained first. This guide covers only the specific moment where that workflow runs out: you have searched, and nothing in the current release describes your device.

The Two-Step Answer

MDR Article 26 and IVDR Article 23require the Commission to make an internationally recognised medical devices nomenclature available free of charge, and EMDN is what the Commission designated to meet that requirement. The FAQ on EMDN endorsed by the Medical Device Coordination Group, MDCG 2021-12 Rev.2, answers the "no code fits" question directly at Question 14, and it is a two-step answer, not one:

1. Assign the code extension 99 (term "Other") to the device, within the type where it belongs, "as indicated in Question 9" (the general rule that manufacturers must always assign the most granular terminal code available).
2. Separately, make a proposal in the EMDN submission platform, or through the MDCG Nomenclature Working Group, for the creation of a new level (a new code and term), with a thorough description of the device. MDCG 2021-12 Rev.2 adds that "manufacturers are also encouraged to notify of such potential new code needs early in the certification process."

Step one gets your device correctly, defensibly registered today. Step two is how the nomenclature itself gets fixed, and it runs on its own multi-month cycle, covered below. They are independent. You do not need to wait for step two to complete step one. The FAQ phrases step two as a recommendation, not a legal duty, but it is the only way a more specific code will ever exist for your device.

Search First, Properly

Extension 99 is not a shortcut around searching. MDCG 2021-12 Rev.2 Question 13 states it plainly: "the user should always search the most granular (lowest) levels of the nomenclature for the most appropriate EMDN term" and "it remains the sole responsibility of the manufacturer to review the entire nomenclature for the identification of the most appropriate term to report." Only once that search comes up empty does the same answer say the manufacturer "may assign the code extension '99'."

Question 7 of the same document describes the two search methods the Commission expects you to combine: top-down navigation through the seven-level hierarchy from category to terminal code, and keyword-based search across different word combinations, synonyms and word orders. For the keyword method it advises "a bottom-up check" to confirm the code you land on sits in the right branch. EMDN is revised annually, so a code that did not exist last year may exist in the current release; re-run the search against the current EMDN version, not a downloaded copy from an earlier registration cycle.

Assigning Extension 99

Many EMDN branches carry a level ending in extension 99, term "Other". In EMDN v2026, 1,103 of the 1,743 non-terminal codes have one, so check that your branch does. This level is deliberately generic. It is the terminal fallback for devices the specific codes beside it do not cover. It is easy to confuse with the superficially similar extension 90("Various"), and MDCG 2021-12 Rev.2 Question 6 exists specifically to separate the two:

• Extension 99 ("Other") levels are terminal. A UDI-DI can be registered against one.
• Extension 90 ("Various") levels are not terminal: they are broken down further elsewhere in the tree, and "no UDI-DI can be associated to a code extension '90' for the registration in EUDAMED."

A worked example makes the distinction concrete. Blood bags and kits sit under category B (Haematology and Haemotransfusion Devices), group B01. Two of its level-3 codes have almost identical names:

B0190 looks like a fallback because of its plain wording, but assigning it to a UDI-DI is not possible: EUDAMED requires a terminal code, and B0190 is not one. B0199 is the actual fallback, It sits beside B01's specific children (collection, transfer, medullary, placental and umbilical cord blood bags and kits) for devices none of them describe. This exact 90/99 pair recurs throughout EMDN, down to the deepest levels of the tree: a seven-level example is H020301040199, "Single Patient Straight Linear Staplers With Blade For Videosurgery, Other," under category H (Suture Devices). Extension 99 is not confined to shallow branches; whichever level of the tree your device's closest match sits at, that level is where you look for its 99 sibling first, before falling back to a shallower one.

The European Commission also operates a dedicated EMDN helpdesk for navigation questions, separate from the code-request channels covered below: it "aims to provide users with information on the nomenclature structure" and help with choosing between existing codes. It is reachable through the EMDN Helpdesk portal, with technical access issues routed to SMEMDN@regione.fvg.it. It is the right first stop if you are unsure whether 99 is genuinely correct for your device, before you register anything.

Requesting a New Code

Assigning extension 99 closes the immediate registration problem; it does not fix the nomenclature. MDCG 2024-2 Rev.1 sets out two separate channels for that, and manufacturers do not have equal access to both.

The annual procedure

This is the standard route and the only one open to manufacturers directly. It runs in four fixed phases every year:

The submission platform is open to a wide list of proposers, including competent authorities, notified bodies, the WHO, trade associations, manufacturers, authorised representatives, importers and distributors, but MDCG 2021-12 Rev.2 Question 24 notes that when multiple requests land on the same code, prioritisation "could be based on the order of arrival and their role," with role split into three tiers: Member States, notified bodies and the WHO first; economic operators and trade associations second; health professionals, hospitals, laboratories and other users third. There is no guarantee a given year's request is accepted; Question 26 sets out what a request can ask for (new levels for device types not yet represented, clarified or corrected terms, deletion of codes that no longer serve a purpose, moving misplaced levels), and a rejected request can be resubmitted in a later cycle.

The ad-hoc procedure

A separate, expedited pathway exists for urgent cases, but manufacturers cannot use it directly. MDCG 2024-2 Rev.1 labels it a pilotprocedure and states "only requests submitted by competent authorities and notified bodies qualify under the ad-hoc procedure." It only covers requests for genuinely new codes, not splits or obsoletions of existing ones, and requires a detailed justification form (device description, intended purpose, why existing codes do not work, the EMDN branch the new code should sit under) sent to SANTE-EMDN@ec.europa.eu. A manufacturer with a time-sensitive gap has to raise it with its notified body or a competent authority to have it routed this way; there is no manufacturer-initiated expedited channel.

Keep a Record

Nothing in MDCG 2021-12 Rev.2 creates a standalone paperwork obligation for choosing extension 99. But two things it does say make a written record worth keeping anyway. First, Question 13 puts the burden of the search itself on the manufacturer: "it remains the sole responsibility of the manufacturer to review the entire nomenclature." Second, the note under Question 13 says UDI-DIs carrying extension 99 get additional scrutiny during the annual EMDN review procedure. A dated record of your search is how you show the choice was genuine if anyone asks.

A short, dated note is enough: what search terms and branches you checked, the closest non-matching codes you considered and why they did not fit, and the date and EMDN version you searched. Keep it with the device's technical documentation rather than as a separate artefact, so it travels with the record a Notified Body would actually review.

What Happens Later

Two things can happen after you register with extension 99, on two different timelines. If the Commission accepts a new-code proposal covering your device, in your own cycle or someone else's, MDCG 2021-12 Rev.2 Question 14(c) is explicit that manufacturers "must reflect this change and update their registration in EUDAMED and in all related regulatory documentation." Separately, Question 28 states manufacturers and notified bodies "are expected to reflect" any EMDN code update in their documentation and in EUDAMED "at the latest prior to the next annual surveillance audit following the finalisation of the annual EMDN update cycle," an expectation rather than a hard deadline written into the regulation itself. Since the Commission does not notify individual manufacturers of relevant changes (Question 17), the same answer recommends making it standard practice to check each annual EMDN publication against your own product portfolio ahead of that audit.

For what happens to a code that gets rendered obsolete or split once a more specific replacement exists, and the EUDAMED-side mechanics of that transition, see the EUDAMED rejection reasons guide, which covers the business-rule references in detail.

Common Mistakes

Search to the bottom of the tree first. If nothing more specific exists, assign extension 99 within the correct branch and keep a dated record of the search. Use the annual submission platform if you want a specific code to exist in a later release.

Frequently Asked Questions