BS EN ISO 20417:2026 - TC

This standard BS EN ISO 20417:2026 - TC Tracked Changes. Medical devices. Information to be supplied by the manufacturer is classified in these ICS categories:

• 01.110 Technical product documentation
• 11.120.01 Pharmaceutics in general
• 11.040.01 Medical equipment in general

NOTE 1        There is guidance or rationale for this Clause in A.2.1. This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied. NOTE 2        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 document.