Medical devices standards package

Standards package "Medical devices" Medical devices standards package

Scope

The standards package includes the most demanded and widely applicable standards on medical devices. Three of them - BDS EN ISO 13485:2016, BDS EN ISO 14971:2020 and BDS 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.
The standards package offers the following documents:
- BDS EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- BDS EN ISO 13485:2016/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- BDS EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- BDS EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
- BDS EN ISO 15223-1:2021/A1:2026 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/Amd 1:2025)
- BDS EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
- BDS EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
- BDS EN ISO 14971:2019/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
- SD CEN ISO/TR 24971:2020 Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)