Harmonised Standards under EU MDR / IVDR: EC Publishes New Implementing Decisions (EU) 2024/815 and (EU) 2024/817

11 March 2024

Harmonised Standards for Medical Devices: Further Amendment of Implementing Decision (EU) 2021/1182

On 8 March 2024, Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for single-use medical gloves, biological evaluation of medical devices, sterilization of healthcare products, packaging for medical devices to be sterilized in the final packaging and reprocessing of healthcare products was published in the Official Journal of the European Union.