ISO/DIS 20417 “Medical Devices — Information to Be Supplied by the Manufacturer.”

The International Organization for Standardization (ISO) has released a draft version of the ISO/DIS 20417 standard, titled “Medical Devices — Information to Be Supplied by the Manufacturer.” Published on November 29, 2024, this draft underscore the vital role of clear, consistent, and comprehensive information provided by manufacturers to ensure safety and compliance in the medical device industry.

The updated standard seeks to harmonize requirements for the information manufacturers must supply with their devices, such as instructions for use, safety warnings, and performance details. By standardizing these elements, the draft aims to improve transparency and usability for both healthcare professionals and end users, ultimately enhancing patient safety.

This new version also addresses the growing complexity of the medical device market, including digital and software-based devices. It provides guidelines to ensure that manufacturers meet regulatory expectations while facilitating global market access.

Stakeholders across the medical device sector are encouraged to review and provide feedback on this draft to help shape the final version, promoting a shared commitment to quality and safety in the industry.