The standards package includes the most demanded and widely applicable standards on medical devices. Three of them - EN ISO 13485:2016, EN ISO 14971:2020 and EN ISO 15223-1:2021 - are harmonized under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The standards in the collection enjoy considerable international success and provide a proven framework for the requirements related to the quality management of medical devices; the risk management process throughout all phases of the medical device life cycle; symbols used in information provided by the manufacturer and requirements for information provided by the manufacturer for medical devices.
Standards package "Medical devices"
