Senior Consultant IVD - RA
3 articles
On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG 2024-13) on the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. In addition, the MDCG released its first revision (MDCG 2022-5 Rev 1) of the guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
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On October 30th, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the obligation to inform in case of interruption or discontinuation of supply. This document provides a Q&A related to Article 10a as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746.
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Understanding the impact of EU IVDR on clinical trials and the changes it brings. Stay informed and compliant with the latest regulations.
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