ISO 20417:2021 is a pivotal standard in the medical device industry, focusing on the comprehensive information that manufacturers must provide with their products. It replaces the previous standard, EN 1041, and provides detailed requirements for the information that medical device manufacturers must provide with their products to guarantee their safe and effective use by healthcare professionals and patients. This blog will delve into the essential aspects of ISO 20417:2021, its requirements, and its importance in the medical device sector.
Introduction to ISO 20417:2021
ISO 20417:2021, titled "Medical Devices — Information to be Supplied by the Manufacturer," sets forth guidelines on the type and extent of information that must accompany medical devices. This standard aims to ensure that users have access to all the information necessary to use the devices safely and effectively, thereby promoting overall safety and regulatory compliance. This standard complements ISO 15223 by outlining the broader requirements for the labeling and information supplied with medical devices.
ISO 20417:2021 was developed to align with updated regulations and provide a comprehensive standard for medical device information. It takes into account several regulatory documents, including:
MDR (EU) 2017/745: European Union Medical Device Regulation
IVDR (EU) 2017/746: EU In Vitro Diagnostic Regulation
IMDRF/GRRP WG/N47:2018: Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
IMDRF/GRRP WG/N52:2019: Principles of Labelling for Medical Devices and IVD Medical Devices
The standard aims to eliminate confusion caused by inconsistent terminology and differing requirements across various regulations.
Differences Between ISO 20417:2021 and EN 1041
The new standard differs significantly from EN 1041:
Expanded Scope: ISO 20417:2021 is over 80 pages long, compared to EN 1041’s more concise format.
Clear Definitions: Improved terminology and definitions to avoid confusion.
Detailed Requirements: More comprehensive sections on general considerations and specific information elements.
Harmonization with MDR/IVDR: Aligns with updated European regulations for better compliance.
Scope and Application of ISO 20417:2021
ISO 20417 applies to all medical devices, including those used in diagnostic, therapeutic, and monitoring applications. The standard covers a broad range of information requirements, including:
Identification of the device: Information that clearly identifies the device, including its name, model, and unique device identifier (UDI).
Labels: Information on the device itself and its packaging.
Instructions for use: Detailed guidance on how to use the device properly, including setup, operation, and troubleshooting.
Safety warnings and precautions: Critical safety information that users need to know to avoid potential hazards.
Technical specifications: Detailed specifications of the device, including performance characteristics and limitations.
Maintenance and servicing instructions: Guidance on how to maintain and service the device to ensure its continued safe operation.
The standard ensures that manufacturers provide all necessary information to support the safe and effective use of their products.
Key Aspects of ISO 20417:2021
Comprehensive Information: Details the types of information that must be provided with medical devices, including instructions for use, safety information, and technical specifications.
User-Centered: Ensures that the information supplied is accessible and understandable to all users, including healthcare professionals and patients.
Regulatory Compliance: Helps manufacturers meet regulatory requirements by providing clear guidelines on the information that must accompany medical devices.
Key Definitions covered within ISO 20417:2021
One of the significant improvements in ISO 20417:2021 is the clarification of key terms:
Accompanying Information: Information provided with a medical device or accessory, including labels, instructions for use, and technical descriptions.
Label: Written, printed, or graphic information on the device or its packaging.
Marking: Durable information affixed to the device.
Instructions for Use: Essential information for the safe and effective use of the device, provided as a package insert.
Technical Description: Information directed to responsible organizations and service personnel for the device's preparation, use, maintenance, and disposal.
These clear definitions help prevent confusion and ensure a common understanding across the industry.
Key Requirements of ISO 20417:2021
ISO 20417:2021 is structured to provide clear guidance on the requirements for accompanying information. It includes sections on:
General Considerations: Fundamental principles for providing information.
Information Elements to be Established: Specific details that must be included, such as safety warnings and technical specifications.
Risk Management and Usability Engineering: Information must support safe use, designed to be comprehensible for intended users.
Use of Symbols: Symbols can be used in place of text if they are explained in the instructions for use.
Language Codes: ISO 639 codes can be used to label languages in multilingual information.
Date Formatting: Dates must be provided in a consistent format (YYYY-MM-DD).
Label Placement: Labels must be on the device itself unless impractical, in which case they can be on the packaging.
Electronic IFU (eIFU): If provided electronically, this must be stated on the label using an appropriate symbol.
Nanotechnology: Devices containing nanomaterials must be labeled accordingly.
Minimalism in IFU: Instructions should only include necessary information, avoiding unnecessary details.
Website Information: Full instructions for use should be available on the manufacturer’s website, if applicable.
Repackaging and Translation: Third parties repackaging or translating information must provide their name and address on the label.
Comprehensive Instructions for Use: Instructions must be clear, concise, and easy to understand. They should cover all aspects of device operation, from initial setup to decommissioning. Visual aids such as diagrams and illustrations should be included to enhance understanding.
Device Identification: Devices must be clearly labeled with all necessary identifiers. Information should include the device name, model number, batch or serial number, and the UDI. The labeling must be durable and remain legible throughout the device's intended lifecycle.
Safety Information: Safety warnings and precautions must be prominently displayed. Information on potential risks and how to mitigate them should be included. Instructions should also cover what to do in the event of a device failure or malfunction.
Technical Specifications: Detailed technical information about the device must be provided. This should include performance specifications, environmental conditions for use, and compatibility with other devices. Any limitations or contraindications must be clearly stated.
Maintenance and Servicing: Clear instructions on how to maintain and service the device to ensure its proper functioning. Information on routine maintenance tasks, recommended service intervals, and troubleshooting tips should be provided. Guidance on how to obtain replacement parts and technical support should also be included.
Integrating ISO 15223 and ISO 20417
Together, ISO 15223 and ISO 20417 provide a comprehensive framework for medical device labeling and information. By adhering to these standards, manufacturers can ensure that their products are labeled accurately and provide all necessary information to users. This integration enhances safety, regulatory compliance, and international market access.
ISO 20417:2021 is a vital standard that underscores the importance of providing comprehensive information with medical devices. By adhering to this standard, manufacturers can ensure that their products are used safely and effectively, thereby enhancing patient safety and meeting regulatory requirements. For healthcare professionals and patients, this translates into greater confidence in the devices they use and rely on.
Artixio : Your trusted Partner for Medical Device Regulatory Compliance
For more detailed information on ISO 20417:2021 and other medical device standards or assistance with compliance, feel free to reach out to us at info@artixio.com. Our team of experts is here to help you navigate the complexities of medical device regulations.
Stay informed, stay compliant, and ensure the highest standards of safety and efficacy in your medical devices.
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