EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12) EN ISO 20417:2021

General information

60.60 Standard published   May 5, 2021


CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

11.040.01   Medical equipment in general


NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for 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.

Life cycle


EN 1041:2008+A1:2013


EN ISO 20417:2021
60.60 Standard published
May 5, 2021


prEN ISO 20417 rev