EU Commission Updates Harmonized Standards for Quality Management in Medical Devices

The Commission of the European Union (EU) has updated its list of harmonized standards for quality management systems and risk management practices applicable to medical devices under the EU’s In Vitro Device Regulation (EU 2017/746, or IVDR)

Published in the Official Journal of the European Union, Commission Implementing Decision (EU) 2022/729 now adds ISO 14971:2019, “Medical devices—Application of risk management to medical devices,” as well as its 2021 amendment, ISO 14971:2019/A11:2021, to the list of harmonized standards applicable to in vitro medical devices.

The Commission’s Implementing Decision also corrects an omission from its earlier list of harmonized standards, now adding ISO 13485:2016/AC:2018, a corrigendum to ISO 13485:2016, “Medical devices—Quality management systems-Requirements for regulatory purposes.”

The text of the Commission’s Implementing Decision updating its list of harmonized standards for quality management systems and their application to medical devices under the EU’s IVDR is available at the Eur-Lex website.