Summary

Specifies the requirements for information to be supplied by the manufacturer with or about a medical device, including labelling, instructions for use (IFU), and technical descriptions. Replaces EN 1041 and is harmonized under the EU MDR/IVDR.

Standard Details

Standard Number: ISO 20417:2021
Type: ISO Standard
Published by: ISO
Official Link: https://www.iso.org/standard/76334.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.

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ISO 20417:2021 — Medical devices — Information to be supplied by the manufacturer

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