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Glossary Term
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ISO 20417 (Information to Be Supplied by the Manufacturer of Medical Devices)

Definition

ISO 20417 is an international standard that specifies the requirements for the information manufacturers must supply with medical devices. This includes labeling, instructions for use (IFU), and any other documentation necessary for the safe and effective use of the device. The standard harmonizes these requirements across global regulatory frameworks.

Relevance to the MedTech Industry

ISO 20417 ensures that medical devices are accompanied by comprehensive and clear information, enabling users, patients, and healthcare professionals to understand the proper operation, limitations, and risks associated with the device. It also facilitates regulatory compliance by aligning with standards like EU MDR and FDA guidelines.

Additional Information & Related Terms

Key Components of ISO 20417

  1. Labeling Requirements

    • Specifies what information must be included on device labels, such as the name of the manufacturer, device identifiers, and usage limitations.

  2. Instructions for Use (IFU)

    • Defines the scope, format, and content of user instructions to ensure safe and effective operation of the device.

  3. Electronic Instructions

    • Allows for the provision of electronic instructions when appropriate, with guidelines for accessibility and usability.

  4. Symbols and Regulatory Information

    • Mandates the inclusion of standardized symbols (e.g., from ISO 15223) and regulatory markings like CE marking.

  5. Device-Specific Considerations

    • Provides guidance on tailoring supplied information to the device type, intended user, and usage environment.


Examples of Applications

  • Surgical Instruments: Clear instructions on cleaning, sterilization, and maintenance procedures.

  • Implantable Devices: Documentation covering implantation techniques, contraindications, and follow-up care requirements.

  • Diagnostic Devices: Step-by-step instructions and safety information for proper operation of IVD kits.

  • Home-Use Devices: User-friendly instructions and warnings tailored to non-professional caregivers.

Related Terms

  • ISO 15223: Provides standardized symbols for use in medical device labeling, complementing ISO 20417.

  • Instructions for Use (IFU): A critical component of ISO 20417, specifying how users should operate and maintain the device.

  • Regulatory Compliance: Ensures supplied information meets the documentation requirements of frameworks like EU MDR and FDA.

  • Post-Market Surveillance (PMS): Feedback from post-market use often informs updates to labeling and instructions.

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