Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · ISO and IEC standards for MedTech and pharma

ISO 20417

Also known as: ISO 20417:2021, EN ISO 20417:2021, Information to be supplied by the manufacturer

ISO 20417 is the international standard for the information to be supplied by the manufacturer of a medical device or accessory. It specifies general requirements for identification, labels, instructions for use, other accompanying documents and their electronic forms.

  • Standards
  • MDR
  • IVDR
  • Technical documentation

In one sentence

ISO 20417:2021 sets general requirements for information supplied with medical devices: identification, labels, IFU and accompanying documents.

Example

A manufacturer of reusable surgical instruments uses ISO 20417 to check that the label carries the required identification and that the instructions for use include reprocessing information, the date of issue and the revision of the document.

How it applies

  • Legal hook: Section 23 of Annex I MDR and Section 20 of Annex I IVDR set out what the label and the instructions for use must contain. ISO 20417 structures these contents at standard level; check the current list of harmonized standards before relying on it for presumption of conformity.
  • Predecessor: In Europe, EN ISO 20417:2021 replaced EN 1041, the earlier standard on information supplied by the manufacturer.
  • Content: Identification of the device and manufacturer, labeling of the device and its packaging, instructions for use, accompanying documents, and electronic forms of information.
  • Family standards: Product standards and particular standards add specific content; ISO 20417 provides the general layer. Symbols follow ISO 15223-1.
  • Electronic IFU: Supplying instructions electronically in the EU is governed by Implementing Regulation (EU) 2021/2226; the standard doesn't replace its conditions.
  • Technical documentation: Labels and IFUs are controlled documents in the technical documentation. A traceability matrix from the Annex I requirements to each label field and IFU section makes the evidence reviewable.

ISO 20417 vs. ISO 15223-1

ISO 20417 defines the information content and where it must appear. ISO 15223-1 defines symbols that can express part of that content. A label can meet ISO 15223-1 and still miss information required by ISO 20417 or the MDR.

By knowledge.aitechdoc.world · Published September 25, 2026 · Last reviewed

Source: ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer

Definitions follow the cited standards and specifications. Where a source is a copyrighted publication, such as an ISO, IEC or EN standard, the definition is a close paraphrase, not a verbatim quotation, so as not to infringe copyright. We recommend reading the original publication. The sections “How it applies” are editorial commentary by AI TechDoc Knowledge and are not part of any standard.

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