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.