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.

New

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

Amended

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)

• Commission Implementing Decision (EU) 2022/729 as of 11 May 2022
• Commission Implementing Decision (EU) 2022/15 of 6 January 2022
• Commission Implementing Decision 2021/1195 of 19 July 2021

Update 6 June 2022

A draft request has been presented to amend the list of EU MDR/IVDR harmonized standards.

• Request to remove:
  • ISO 9978 on radiation protection
  • ISO 14117 on active implantable medical devices
  • ISO 14708-1 on implants for surgery
  • ISO 27185 on cardiac rhythm management devices
  • ISO 27186 on active implantable medical devices
  • IEC TR 60601-4-5 on medical electrical equipment
• Request to add (and have available by 27 May 2024):
  • EN ISO 1135-4:2015 on transfusion equipment for medical use
  • EN ISO 1135-5:2015 on transfusion equipment for medical use
  • EN ISO 10651-4:2009 on lung ventilators
  • prEN 1865-6 on patient handling equipment used in road ambulances
  • EN ISO 11737-3 on sterilization of health care products
  • ISO 18362:2016/DAMD1 on manufacture of cell-based health care products
  • EN ISO 22441 on sterilization of health care products
  • prEN ISO 80369 on small-bore connectors for liquids and gases in healthcare applications
  • prEN ISO 80601-2-84 on medical electrical equipment
  • a standard on respiratory infection prevention devices for self- and third party protection
  • EN ISO 11737-3 on sterilization of health care products
  • ISO 13004 on sterilization of health care products
  • ISO 18362:2016/DAMD1 on manufacture of cell-based health care products
  • EN ISO 22441 on sterilization of health care products

The request is addressed to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) and the review deadline is 30 June 2022.