MDR harmonised standards update

Harmonisation of standards under Regulation (EU) 2017/745 on medical devices (MDR) is further progressing. The table below shows the standards that have been published in the Official Journal of the EU (OJEU) in January 2022 as giving a ‘presumption of conformity’ with the MDR.

Fortunately, EN ISO 13485 is included in the list, but the harmonised version of the risk management standard, EN ISO 14971:2019 with its amendment A11:2021 is yet to be published in the OJEU. 

Standard ReferenceStandard Title
EN ISO 10993-92021Biological evaluation of medical devices-Part 9: Framework for identification and quantification of potential degradation products
EN ISO 10993-12:2021Biological evaluation of medical devices-Part 12: Sample preparation and reference materials 
EN ISO 13408-6:2021Aseptic processing of health care products-Part 6: Isolator systems 
EN ISO 14160:2021Sterilisation of health care products-Liquid chemical sterilising agents for single-use medical devices using animal tissues and their derivatives-requirements for characterisation, development, validation and routine control of a sterilisation process for medical devices-Part 1: General requirements 
EN ISO15223-1:2021Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements 
EN ISO 17664-1:2021Processing 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
EN ISO 11737-1:2018Sterilisation of health care products-Microbiological methods-Part 1:Determination of population of microorganisms on products 
EN ISO 13485:2016Medical devices-Quality managements systems-Requirements for regulatory purposes 
EN IEC 60601-2-83:2020Medical electrical equipment-Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment 

The full list of MDR harmonised standards can be accessed here (bitte mit https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en verlinken).

Source: Medtech Insight (an Informa product)

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