ISO 20417-2021 PDF

Full title and description

ISO 20417:2021 — Medical devices — Information to be supplied by the manufacturer. This International Standard specifies the information elements and general requirements for identification, labeling, marking, packaging and accompanying information (including instructions for use and technical descriptions) that manufacturers shall provide for medical devices and accessories.

Abstract

ISO 20417:2021 defines the required and conditional information to be supplied by the manufacturer for a medical device or accessory. It covers device and manufacturer identification, labelling and marking (including symbols), packaging information, requirements for accompanying information (printed, electronic, audio or tactile), language and date formats, legibility and durability, and special provisions for sterile or reusable devices. The standard does not prescribe the format or delivery means for the information and defers to product-specific or jurisdictional requirements where those differ.

General information

• Status: Published (under review for revision; ISO stage 90.92).
• Publication date: 13 April 2021 (corrected versions published December 2021).
• Publisher: ISO (International Organization for Standardization).
• ICS / categories: 11.040.01 — Medical equipment in general.
• Edition / version: Edition 1 (2021).
• Number of pages: 72 (official ISO publication; corrected version 2021-12).

Scope

This document specifies requirements for the information supplied by the manufacturer of a medical device or of an accessory. It includes general requirements for identification and labels on the device or accessory, packaging, marking, and accompanying information. ISO 20417 does not specify the means by which the information is supplied and recognizes that authorities having jurisdiction or product-specific standards may impose additional or different requirements. Informative annexes provide test method examples for legibility and durability and cross references to related regulatory and standards documents.

Key topics and requirements

• Definitions and general considerations for manufacturer-supplied information (labels, marking, packaging, accompanying information).
• Identification elements: required, conditional and optional data (product/brand name, model/catalogue number, production identifiers, UDI elements where applicable).
• Requirements for instructions for use (IFU) and technical descriptions (content, audience differentiation, e-documentation options, updates).
• Labelling content rules: manufacturer name and address, device identification, safety information, storage/handling, sterility and reuse statements, and applicable symbols (referencing ISO 15223‑1 and related symbol standards).
• Format conventions: date formats (ISO 8601), units, language and country identifiers, and graphical information guidance.
• Legibility and durability expectations and example test methods for markings and accompanying information.
• Supply-chain and economic-operator information: importers, distributors, repackagers, translation responsibilities and when additional information must be supplied by other parties.
• Cross‑references to risk management (ISO 14971), IMDRF labelling principles and product‑specific/regulatory requirements that take precedence.

Typical use and users

Primary users: medical device manufacturers (regulatory and quality teams), design and clinical engineers, technical writers producing IFUs and labels, regulatory affairs specialists, notified bodies and regulators, importers/distributors and contract manufacturers responsible for repackaging or translation. Typical uses include preparing or reviewing labelling and accompanying documentation to meet international expectations, aligning technical files for conformity assessment, and designing legible, durable, and compliant IFUs and packaging.

Related standards

Commonly referenced standards and documents include ISO 15223-1 (symbols for medical device labels, labeling and information), ISO 14971 (risk management), ISO 16142-1/2 (essential principles and information requirements), IMDRF labelling guidances (e.g., GRRP documents), and applicable regional regulations (e.g., EU MDR/IVDR, FDA labelling and UDI requirements). Product-specific standards take precedence where they conflict with ISO 20417.

Keywords

medical device, labelling, marking, packaging, instructions for use (IFU), accompanying information, information supplied by the manufacturer, UDI, symbols, legibility, durability, ISO 20417, manufacturer information, device identification.

FAQ

Q: What is this standard?

A: ISO 20417:2021 is an international standard that specifies what information a manufacturer must supply with a medical device or accessory (labels, marking, packaging and accompanying information) to support safe and effective use.

Q: What does it cover?

A: It covers required and conditional information elements (device and manufacturer identification, UDI where applicable, model/catalogue numbers, sterility/reuse statements), conventions for dates/units/languages, content expectations for IFUs and technical descriptions, legibility and durability, and supply-chain information. It does not mandate the format or medium of delivery and defers to product-specific and jurisdictional requirements.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory and quality personnel, IFU/label authors, design/clinical engineers, notified bodies and regulators, and economic operators in the supply chain.

Q: Is it current or superseded?

A: ISO 20417:2021 is the current published edition (published April 2021, corrected December 2021). ISO indicates the document is in the review lifecycle and may be subject to revision (stage 90.92). Users should verify national adoptions or later revisions before relying on the standard for compliance activities.

Q: Is it part of a series?

A: It is related to a family of medical device standards (e.g., ISO 15223-1 for symbols, ISO 14971 for risk management, ISO 16142 for essential principles and information) and is frequently referenced alongside regulatory guidance such as IMDRF labelling documents and regional regulations (EU MDR/IVDR, FDA). It complements product-specific standards rather than forming a numbered series of ISO parts.

Q: What are the key keywords?

A: Manufacturer information, labelling, IFU, UDI, device identification, packaging, marking, symbols, legibility, durability, regulatory compliance.