Labeling and Symbols
ISO 20417: Information Supplied by the Manufacturer
ISO 20417 sets general requirements for the information a manufacturer supplies with a medical device or accessory: what goes on labels and packaging, what goes into instructions for use and other accompanying information, and how it is presented.
At a Glance
- Standard
- ISO 20417
- Subject
- Information Supplied by the Manufacturer
- Group
- Labeling and Symbols
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The standard is horizontal. It applies across device types and sets a common baseline, while product-specific standards and regulations add their own content on top. It addresses identification of the device and manufacturer, information on labels and packaging, the content of instructions for use and technical descriptions, and electronic forms of accompanying information.
It works alongside ISO 15223-1, which supplies the symbols, and alongside risk management under ISO 14971, since information for safety is one of the risk control options and residual risks may need to be disclosed to users. Usability engineering matters here too, because instructions that users misread don't reduce risk.
For device makers selling into several markets, ISO 20417 helps build one labeling structure that is then adapted to each jurisdiction's specific rules, such as FDA labeling requirements and the EU MDR's information requirements.
Who It Applies To
- Manufacturers writing or revising labels and instructions for use
- Firms providing instructions for use in electronic form
- Regulatory teams harmonizing labeling across markets
- Accessory and component suppliers that supply information with their products
What Auditors Check
Required Content by Market
A defined list of required label and instructions content for each market, traced to the requirement it comes from.
Risk Disclosure
Warnings and residual risks in the instructions for use consistent with the risk management file.
Labeling Under Design Control
Labeling treated as a design output, verified against inputs and validated with users where needed.
Electronic Instructions Controls
Where instructions are supplied electronically, controls on availability, versioning and access to paper copies where required.
Version Traceability
A revision history linking each label and instructions version to the product configurations it ships with.
Related Services
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Industry Guides That Reference ISO 20417
ISO 20417
Check Your Quality System Against ISO 20417
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
