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.
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.