On March 8th 2024 the EU Commission published in the Official Journal of the European Union (OJEU) two Commission implementing decisions concerning new references of harmonised standards in support of Regulation (EU) 2017/745 on medical devices (MDR) and of Regulation (EU) 2017/746 (IVDR).
For the MDR: 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. Click this link for a copy of the implementing decision.
For the IVDR: Commission 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. Click this link for a copy of the implementing decision.
