EVS-EN ISO 20417:2021

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

General information
Valid from 17.05.2021
Base Documents
ISO 20417:2021; EN ISO 20417:2021
Directives or regulations

Standard history

Main + amendment
ISO 20417 provides the requirements for the identification and labels on a medical device. It also includes requirements for packaging, marking of a medical device or accessory, and accompanying information. The aim of ISO 20417 is to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a particular medical device or group of medical devices.

The requirements of a medical device product standard or a group standard can use these general requirements. This document should not be used separately when there is a conflict and a product standard or a group standard exists. Specific requirements of medical device product standards or group standards take precedence over the requirements of this document. Unless specified otherwise within a product standard or a group standard, the general requirements of this document apply.

The text of ISO 20417:2021 has been approved in Europe as EN ISO 20417:2021 without any changes.
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