EU MDR/IVDR Update!!
The Medical Devices Harmonised Standards have been updated with the two implementing decisions published by the European Commission.
“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.” It 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.” It includes the following entries to the list of standards: EN ISO 11137-2:2015; EN ISO 11607-1:2020; EN ISO 11607-2:2020.
Decision (EU) 2024/815: https://lnkd.in/eiARD-a2
Decision (EU) 2024/817: https://lnkd.in/eGe2piuU
Know more about our Medical Devices Harmonised Standards expertise at https://lnkd.in/dt4tQYNy