List of harmonized standards under Regulation (UE) 2017/745

For your information the European Commission has just published the implementing decision (UE) 2022/757 amending the list of harmonized European standards under Regulation (EU) 2017/745. The updates refer the following standards:

• EN ISO 13485:2016 on quality management systems: addition of the reference of corrigendum EN ISO 13485:2016/AC:2018 with retroactive effect.
• EN 285:2015+A1:2021 Sterilization – Steam sterilizers – Large sterilizers: addition of this standard to the list of harmonized standards.
• EN ISO 14971:2019 on the application of risk management: addition of this standard to the list of harmonized standards.

This decision enters into force on the day of its publication i.e. on 17 May 2022.

DOWNLOAD THE IMPLEMENTING DECISION (EU) 2022/757