Earlier this week new Harmonized European standards were adopted to be published in the Official Journal of the European Union (OJEU). The updates can be found here.
This update is important because conformance to harmonized standards presumes conformity to the requirements of the legislation. The standards harmonized under the old Directives are being transitioned to the MDR/IVDR over time.
EN ISO 14971:2019, as amended by EN ISO 14971:2019/A11:2021, Medical Devices – Application of Risk Management to Medical Devices (ISO 14971:2019)
EN 285:2015+A1:2021, Sterilization – Steam Sterilizers – Large Sterilizers
EN ISO 13485:2016/A11:2021, Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
“The references of harmonised standard EN ISO 13485:2016 on quality management systems and its amendment EN ISO 13485:2016/A11:2021 are published…
However, that publication does not include the reference of the corrigendum to that standard – EN ISO 13485:2016/AC:2018. The corrigendum corrects only formal aspects of the European foreword and of the informative annexes, without affecting the substance of the harmonised standard.
In order to ensure that corrections made by EN ISO 13485:2016/AC:2018 apply for the purposes of the presumption of conformity with the relevant requirements of Regulation (EU) 2017/745 / 2017/746, it is necessary to include the reference of that corrigendum in Implementing Decision (EU) 2021/1182.
For reasons of legal certainty, the reference of corrigendum EN ISO 13485:2016/AC:2018 should be published in the Official Journal of the European Union with retroactive effect.”
List of standards currently harmonized under the EU MDR (see Annex of each document for list)
- Commission Implementing Decision (EU) 2022/757 as of 11 May 2022
- Commission Implementing Decision (EU) 2022/6 as of 4 January 2022
- Commission Implementing Decision 2021/1182 as of 16 July 2021
List of standards currently Harmonized under the EU IVDR (see Annex of each document for list)