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European Commission publishes two implementing decisions on medical device harmonised standards

By March 21, 2024No Comments

The European Commission have published two Implementing Decisions regarding medical device harmonised standards:

  • “Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products.”This Implementing Decision includes the following entries to the list of standards:
    • EN 455-3:2023
    • EN ISO 10993-15:2023
    • EN ISO 10993-17:2023
    • EN ISO 10993-18:2020
    • EN ISO 11137-2:2015
    • EN ISO 11607-1:2020
    • EN ISO 11607-2:2020
    • EN ISO 17664-2:2023
  • “Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices.”This Implementing Decision includes the following entries to the list of standards:
    • EN ISO 11137-2:2015
    • EN ISO 11607-1:2020
    • EN ISO 11607-2:2020
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