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.