What is BS EN ISO 20417:2021 Medical devices about?
This international standard detail the information that medical device manufacturers should supply with their products. BS EN ISO 20417:2021 replaces the European standard BS EN 1041:2008+A1:2013.
Who is BS EN ISO 20417:2021 Medical devices for?
- All parts of the medical devices industry
- CEOs, compliance and legal teams in the medical devices industries
- Regulators
Why should you use BS EN ISO 20417:2021 Medical devices?
It specifies the information to be supplied by medical device or medical device accessory manufacturers. It covers general requirements, medical device identification, requirements for packaging, requirements for marking and information on the label, and requirements for accompanying documentation.
BS EN ISO 20417:2021 aims 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 or group of medical devices. The requirements of a medical device product standard or a group standard can make use of these general requirements.
Use of the standard can help medical device manufacturers:
- Comply with the requirements of the MDR
- Enter new market
- Develop their product information expertise
- Facilitate trade
- Manage risk
- Increase trust in their products
NOTE: Some authorities with 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 the requirements of this document.
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.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.
