MDR: New harmonised standards

The Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment has been published in the Official Journal of the European Union (OJEU) and entered into force on 5 January 2022.

The Annex to the Decision contains 9 additional references of EN ISO/EN IEC harmonised standards. These are ready to be accessed by the manufacturer in order to presume conformity to the legal requirements they cover.


Reference of the standard


EN ISO 10993-9:2021

Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)


EN ISO 10993-12:2021

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)


EN ISO 11737-1:2018

Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

EN ISO 11737-1:2018/A1:2021


EN ISO 13408-6:2021

Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)


EN ISO 13485:2016

Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13485:2016/A11:2021


EN ISO 14160:2021

Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)


EN ISO 15223-1:2021

Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)


EN ISO 17664-1:2021

Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)


EN IEC 60601-2-83:2020

Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

EN IEC 60601-2-83:2020/A11:2021’.

Source: OJEU

We have informed you of the first release of harmonised standards on MDlaw – click here for more information.

All implementing acts concerning harmonised standards are available in our MDlaw Library – STANDARDS.

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