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.
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:
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.
Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
ISO 20417:2021
EN ISO 20417:2021