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 Reference||Standard Title|
|EN ISO 10993-92021||Biological evaluation of medical devices-Part 9: Framework for identification and quantification of potential degradation products|
|EN ISO 10993-12:2021||Biological evaluation of medical devices-Part 12: Sample preparation and reference materials|
|EN ISO 13408-6:2021||Aseptic processing of health care products-Part 6: Isolator systems|
|EN ISO 14160:2021||Sterilisation 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 ISO15223-1:2021||Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements|
|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|
|EN ISO 11737-1:2018||Sterilisation of health care products-Microbiological methods-Part 1:Determination of population of microorganisms on products|
|EN ISO 13485:2016||Medical devices-Quality managements systems-Requirements for regulatory purposes|
|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|
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)