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About the checks

What they are

These checks come from the published UDI/Devices business rules, production v2.27.0. A regulatory professional has checked 12 of its 33 rules against that document; the other 21 are unreviewed, so a finding from those is a prompt to look at the source, not an answer.

Official sources checked against their publishers’ sites on 9 Oct 2026 (UTC): all 65 unchanged. A check passes the published rules; whether a device may be registered is your professional judgment.

What is checked

  • Your stored records, against the rules of the release the rule pack names.
  • Every file, against the EU’s own schema for its environment, before it is frozen.
  • Identifier check digits: GS1’s for a GS1 code, EUDAMED’s for its own B- and D- identifiers. A HIBCC, ICCBBA or IFA code is compared with the label by a person.
  • Each EMDN code, against the pinned EMDN list: it must exist and be a lowest-level code.

What is not checked

  • Whether a device must be registered, or under which legislation.
  • Its risk class.
  • Whether the data is true of the device: the checks see only what was entered.
  • Whether EUDAMED will accept a file. Two test files have been accepted in EUDAMED’s Playground, a registration and an update of it; none has been filed in production yet.
  • Whether the portal takes an update of a UDI-DI. An update of a Basic UDI-DI has been applied in the Playground; an update of a UDI-DI has not been tried.

Regindex checks records and files against the published rules. It gives no regulatory or legal advice: whether and how to register a device is your professional judgment.

The sources

  • EUDAMED technical documentation. The business rules, data dictionaries, enumerations, schemas, user guides, release notes and help pages for EUDAMED production (release 2.27, schemas 3.0.30) and the EUDAMED Playground (release 3.31.2, schemas 3.0.32), retrieved from the EU’s EUDAMED help sites between 21 July and 8 October 2026.
  • European Medical Device Nomenclature (EMDN), v2026, English. The nomenclature each device group’s code is checked against, retrieved from the Commission’s EMDN page on 21 July 2026.
  • Commission guidance on UDI and legacy devices. Published on the Commission’s public health website, retrieved on 21 July and 9 October 2026.
  • MDCG guidance. Documents endorsed by the Medical Device Coordination Group, each of which states that it is not a European Commission document. One rule quotes MDCG 2021-25 in a sentence, with its source. MDCG 2019-5, on registering legacy devices, says it was archived in December 2024.
  • EU law. Regulation (EU) 2017/745 as published and as consolidated to 1 January 2026, Regulation (EU) 2024/1860 and Commission Decision (EU) 2025/2371, from the Official Journal through the EU Publications Office, retrieved on 9 October 2026. Cited, and quoted in short with the article.
  • GS1 General Specifications, Release 26.0. The check digit a GS1 identifier is checked with (section 7.9.1), retrieved from GS1’s standards site on 9 October 2026. © GS1 AISBL; cited by section, not reproduced.

Whose material this is

Contains information from the European Commission’s EUDAMED documentation, the European Medical Device Nomenclature and the Commission’s guidance, © European Union, reused under the Commission’s reuse policy (Decision 2011/833/EU), which authorises reuse provided the source is acknowledged. Regindex’s checks, messages and files are its own work built from these sources; the European Commission is not responsible for them.

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