--- title: "ISO 20417, Definition | MedTech Terms" description: "Standard for information to be supplied by the manufacturer of medical devices. Plain-English Standards definition for MedTech teams, with examples and related" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-20417#term", "name": "ISO 20417", "description": "ISO 20417 consolidates the labeling, IFU, and information-supplied requirements that historically lived across multiple device-specific standards. 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This promotes consistency and clarity across the industry." } }, { "@type": "Question", "name": "How does ISO 20417 relate to the EU MDR?", "acceptedAnswer": { "@type": "Answer", "text": "ISO 20417 aligns closely with the general safety and performance requirements (GSPRs) of the EU Medical Device Regulation (EU MDR), particularly those outlined in Annex I regarding information supplied with the device. Compliance with ISO 20417 can help demonstrate conformity with relevant EU MDR requirements." } }, { "@type": "Question", "name": "Is ISO 20417 applicable to all medical devices?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, ISO 20417 applies to all medical devices, regardless of their classification or intended purpose. However, it provides general requirements and may be supplemented by device-specific standards or regulations." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO 20417 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system) # ISO 20417 Standard for information to be supplied by the manufacturer of medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 20417 consolidates the [labeling](/terms/labeling), [IFU](/terms/ifu), and information-supplied requirements that historically lived across multiple device-specific standards. Aligns naturally with EU [MDR](/terms/mdr-reporting) Annex I labeling requirements. What the regulation says ISO 20417, "Medical devices - Information to be supplied by the manufacturer," provides general requirements for information to be supplied by the medical device manufacturer. This international standard is recognized by regulatory bodies worldwide, including the FDA, and aligns with essential requirements for [labeling](/terms/labeling), such as those found in EU [MDR](/terms/mdr-reporting) Annex I. It aims to harmonize labeling requirements across various medical device types and jurisdictions. ## What this means in practice Useful single anchor for global [labeling](/terms/labeling) specifications; FDA recognizes specific clauses. ## Examples - A manufacturer of an implantable cardiac pacemaker uses ISO 20417 to define the content and format of its IFU and device labeling, including warnings, contraindications, and sterile packaging symbols. - A company developing a new diagnostic software application refers to ISO 20417 for guidance on essential information to be displayed on the software interface and in its accompanying documentation. - When preparing a medical device for submission to a regulatory authority like the FDA, a manufacturer ensures that all labeling elements comply with the general requirements specified in ISO 20417. Common pitfalls - • Manufacturers might misinterpret ISO 20417 as a standalone solution, neglecting country-specific labeling requirements that may still apply. - • Failing to regularly update labeling in accordance with new regulations or revised versions of ISO 20417 can lead to non-compliance. - • Companies may overlook the need for clear, unambiguous, and easily understandable language in their labeling, as mandated by the standard. - • Incorrectly applying the general requirements to specific device types without considering supplementary or device-specific standards is a common error. ## Frequently asked questions What is the primary purpose of ISO 20417? The primary purpose of ISO 20417 is to consolidate and standardize the general requirements for information supplied by medical device manufacturers, encompassing [labeling](/terms/labeling) and [Instructions for Use](/terms/ifu) (IFU). This promotes consistency and clarity across the industry. How does ISO 20417 relate to the EU MDR? Is ISO 20417 applicable to all medical devices? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 15223-1 Symbols Recognized graphical symbols for labels, labeling, and information supplied with medical devices. ](/terms/iso-15223-1)[ Regulatory Instructions for Use(IFU) Information supplied by the manufacturer to inform the user of safe use of a device. ](/terms/ifu)[ Regulatory Labeling All written, printed, or graphic matter on or accompanying a device. ](/terms/labeling) ### More in Standards · Same category [ Standards ASTM F2503 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. ](/terms/astm-f2503)[ Standards Essential Performance Performance of a clinical function whose loss or degradation would result in unacceptable risk. ](/terms/essential-performance)[ Standards ICH E6(R3) Good Clinical Practice(E6(R3)) Revision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023. ](/terms/ich-e6-r3)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 IEC· 1 1. [1 ISO 20417 Verified ISO · iso.org ](https://www.iso.org/standard/67943.html) 2. [2 ISO Standards Catalogue - Health Verified ISO · iso.org ](https://www.iso.org/ics/11/x/) 3. [3 IEC Webstore - Medical Equipment Verified IEC · webstore.iec.ch ](https://webstore.iec.ch/searchform&q=medical) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Standards Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=iso-20417) Learn in 60 seconds Card Lesson Quiz Standard for information to be supplied by the manufacturer of medical devices. - · Useful single anchor for global labeling specifications; FDA recognizes specific clauses. - · Aligns naturally with EU MDR Annex I labeling requirements. Remember this Watch out: Manufacturers might misinterpret ISO 20417 as a standalone solution, neglecting country-specific labeling requirements that may still apply. Related terms - [Labeling ](/terms/labeling) - [Instructions for Use(IFU) ](/terms/ifu) - [ISO 15223-1 Symbols ](/terms/iso-15223-1) You may also need Auto-suggested from Standards and shared keywords. - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [IEC 60825 ](/terms/iec-60825) - [IEC 82304-1 ](/terms/iec-82304-1) - [Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) - [AAMI SW96 ](/terms/aami-sw96) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) [All Standards terms](/terms?cat=Standards) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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