A new international standard now details information requirements for medical devices
What’s happened and why?
There’s been a European standard since at least 1998 covering the information that medical device manufacturers should supply with their products. Now that document is being replaced by an ISO standard.
What does BS ISO 20417:2021 cover?
It details requirements for the information to be supplied by medical device and medical device accessory manufacturers. It covers the generally applicable requirements for identification and labels on a medical device or accessory and its packaging, the marking of a medical device or accessory, and the accompanying information. It does not specify the means by which the information is to be supplied.
Why use BS EN ISO 20417:2021?
The standard aims to make life easier for medical device manufacturers by serving 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.
It can also help medical device manufacturers:
- Comply with the requirements of the MDR
- Enter new markets
- Develop their product information expertise
- Facilitate trade
- Manage risk
- Increase trust in their products
The standard’s use also supports UN Sustainable Development Goal 3 on good health and well-being.