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EVS-EN ISO 20417:2026

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)

General information

Valid from 15.04.2026
Estimated date of Estonian translation publication: 08.2026
Base Documents
ISO 20417:2026; EN ISO 20417:2026
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.04.2026
Main
17.05.2021
Main

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.

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