IVDR: New harmonised standards · MDlaw – Information platform on European medical device regulations

The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for 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 and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples has been published in the Official Journal of the European Union (OJEU) and entered into force today – 7 January 2022.

The Annex to the Decision contains 5 additional references of EN ISO harmonised standards. These are ready to be accessed by the manufacturer in order to presume conformity to the legal requirements they cover.

No	Reference of the standard
‘5.	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
6.	EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
7.	EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021
8.	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)
9.	EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)’.

Source: OJEU

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

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