ISO 20417

Purpose and content of the standard

ISO 20417 is the international standard for the information that a manufacturer supplies with a medical device or accessory. Its title is “Medical devices, Information to be supplied by the manufacturer”. According to the description in the entry of the US agency FDA, it sets out general requirements for four areas: the identification and the labels on the product, the packaging, the marking, and the accompanying information. In practice, the latter mainly means the instructions for use (see instructions for use). The standard does not specify the means by which the information is provided, for example on paper or electronically.

Where a separate standard for a product or product group contains particular requirements, these take precedence over the requirements of ISO 20417 according to the FDA entry. It is thus an overarching basis on which product-specific standards build. The text of the standard itself is available only for a fee. This article therefore relies only on publicly available sources and does not reproduce any standard text.

Editions and status

The first edition appeared in April 2021, and a corrected version followed in December 2021. The second edition is dated March 2026 (as of October 2026). On May 25, 2026, the FDA added this second edition as a recognized consensus standard and replaced the recognition of the first edition. The FDA still accepts declarations of conformity to the first edition in regulatory submissions until July 1, 2029.

Anyone preparing documentation should therefore state the edition on which they rely. Which changes the second edition brings in detail cannot be reliably assessed without the text of the standard, which is available only for a fee, and is not presented here.

Relation to the MDR (Annex I, Chapter III)

The European legal framework for the manufacturer’s information is set out in Regulation (EU) 2017/745 (MDR, the European Medical Device Regulation). Annex I, Chapter III is headed “Requirements regarding the information supplied with the device” and contains, as No. 23, the rules on labeling (the label) and instructions for use. No. 23.1 contains the general requirements, No. 23.2 the particulars on the label, No. 23.3 the particulars on the sterile packaging, and No. 23.4 the particulars in the instructions for use.

For design, the requirements of No. 23.1 are particularly important. The medium, format, content, legibility, and placement must suit the product, the intended purpose, and the technical knowledge, experience, education, or training of the intended users. The instructions for use must be written in terms that the intended user easily understands and are to be supplemented by drawings and diagrams where necessary. Residual risks that have to be communicated belong in the manufacturer’s information as limitations, contraindications, precautions, or warnings. Where appropriate, internationally recognized symbols are to be used. Symbols and colors used must conform to the harmonized standards or the common specifications. Where there are none, they are to be described in the documentation supplied. The complete labels and the instructions for use in the languages of the intended markets also form part of the technical documentation under Annex II, No. 2 (see CE marking and technical documentation).

How the standard implements these requirements in detail follows from the text of the standard and is not reproduced here. This article is limited to the finding that the standard covers, in terms of content, the same subject as Annex I, No. 23: the information to be supplied by the manufacturer. No concordance between sections of the standard and MDR numbers is publicly available, and none is claimed.

Harmonization and presumption of conformity

Under Article 8(1), a presumption of conformity with the MDR exists only for devices that conform to harmonized standards (European standards whose references are published in the Official Journal of the European Union). Commission Implementing Decision (EU) 2021/1182 lists these standards for the MDR. In its version of June 17, 2026, it contains no entry for ISO 20417 (as of October 2026). It does list the symbol standard EN ISO 15223-1:2021 including Amendment A1:2025, as well as ISO 13485 and ISO 14971.

It follows that, according to this list, applying ISO 20417 does not give rise to a presumption of conformity for Annex I, No. 23. The manufacturer must demonstrate compliance with the MDR requirements itself. It can use the standard as a recognized aid for this purpose. This is an inference from the legal text and not an express statement by an authority. Whether the list was amended again after June 17, 2026 should be checked in the current consolidated version before this statement is relied on. For manufacturers with a certified quality management system, the term ISO 13485 should also be considered.

Relationship to ISO 15223-1 and IEC 62366-1

ISO 15223-1 governs symbols: according to the FDA entry, it sets out symbols used to express information for a medical device. ISO 20417, by contrast, governs which information the manufacturer supplies. The two complement each other. Annex I, No. 23.1, point (h) requires that symbols conform to the harmonized standards, and for symbols a harmonized standard is on the list, whereas for the scope of information, as of the status mentioned above, none is. The FDA recognized the symbol standard in its fourth edition of 2021 with the amendment of 2025 (as of October 2026).

IEC 62366-1 addresses usability: it describes the process by which the manufacturer designs and evaluates the user interface so that use errors are avoided. According to the understanding of this wiki, the instructions for use are part of the user interface and are to be included in the use-related risk analysis (see IEC 62366-1). ISO 20417 specifies the information content, and IEC 62366-1 checks whether it reaches the intended users. That ISO 20417 itself does not prescribe any procedures for testing usability is an inference from the published scope. It cannot be conclusively substantiated without the text of the standard.

Human factors relevance

For human factors work, labeling (see labeling) and instructions for use are part of the user interface. The MDR requirement to adapt content and form to the intended users corresponds to the core of the usability engineering process: anyone who knows the users, their knowledge, and the use environment can design the information appropriately.

In practice, this means that the manufacturer’s information should be complete and, at the same time, pass the summative evaluation with representative users. Instructions for use that contain all mandatory particulars but are not understood in the test do not fulfill the purpose of Annex I, No. 23.1, point (a). Warnings about residual risks that the risk analysis provides for as an information-based risk control measure should be tested for perceptibility and comprehensibility (see risk management).

Distinction from US labeling

In the US, the legal basis for the labeling of medical devices is 21 CFR Part 801. In its entry for ISO 20417, the FDA names, among the related regulations, parts 801 and 809, part 820, and part 660, among others. The standard is a recognized consensus standard and not a substitute for these regulations. Part 801 applies regardless. This is an inference from the legal nature of the regulation.

One example of the closeness in content: 21 CFR 801.5 defines “adequate directions for use” as directions under which a layperson can use the device safely and for the purposes for which it is intended. The delimitation of the two legal regimes and the significance for the human factors documentation are covered by the FDA human factors guidance. The term the FDA uses is “intended use” and does not correspond without further ado to the term intended purpose in the MDR.

Frequently asked questions (FAQ)

Sources

• Regulation (EU) 2017/745 on medical devices (MDR)
• IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
• ISO 15223-1:2021, Medical devices, Symbols to be used with information to be supplied by the manufacturer, Part 1: General requirements
• ISO 13485:2016, Medical devices, Quality management systems, Requirements for regulatory purposes
• FDA Recognized Consensus Standards, ISO 20417 Second edition 2026-03 (Rec. No. 5-149)
• Regulation (EU) 2017/745 (MDR), consolidated version of 01/01/2026
• Commission Implementing Decision (EU) 2021/1182 on harmonised standards for medical devices, consolidated version of 06/17/2026
• 21 CFR 801.5, Medical devices; adequate directions for use

Related terms

• Labeling
• Instructions for use (IFU)
• MDR (Medical Device Regulation)
• IEC 62366-1
• Usability engineering process
• User interface
• Intended use
• Risk management (ISO 14971)

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