EVS-EN ISO 20417:2026

ISO 20417 specifies the requirements for information supplied by the manufacturer for a medical device or an accessory. This standard includes requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory and accompanying information. ISO 20417 does not specify the means by which the information is to be supplied.

Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. Specific requirements of medical device product standards or group standards take precedence over requirements of this standard.

ISO 20417:2026 text has been approved in Europe as EN ISO 20417:2026 without any changes.