ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer
In April 2021 the new ISO 20417 Medical Devices – Information to be supplied by the manufacturer was published.
This document provides the requirements for the identification and labels, the packaging, marking of a medical device or accessory, and accompanying information. The aim of the standard 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 specific medical device.
The standard can be helpful to medical device manufacturers by:
- Enabling them to comply with the requirements of the MDR
- Facilitate to enter new markets and trade
- Manage more effectively the associated risk
It is to be noted that in case of a conflict or when a specific product standard or a group standard exists, this document should not be used separately. Specific requirements of medical device product standards or group standards take precedence over requirements of this document. But unless specified otherwise, the general requirements of this document apply.
This document specifies the requirements for information which need to be supplied by the manufacturer for a medical device or an accessory. The standard includes the generally applicable requirements for identification and labels, the packaging, marking of a medical device or accessory, and accompanying information. Please note that this document does not specify the means by which the information is to be supplied.
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