BS EN ISO 20417:2021

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

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