Publication of guidance MDCG 2024-1 and ancillary guidances MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, MDCG 2024-1-4

The Medical Device Coordination Group (MDCG) has just published new guidances that describe how to report to competent authorities incidents and serious incidents for specific devices, in accordance with the articles relating to the notification of serious incidents and corrective safety actions and trend reports in Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

Here are the 5 guides recently published:

• MDCG 2024-1: Guidance on the vigilance system for CE-marked devices – DSVG 00 – Device Specific Vigilance Guidance (DSVG)
• MDCG 2024-1-1: DSVG 01 : Devices for Cardiac Ablation
• MDCG 2024-1-2: DSVG 02 : Coronary Stents and associated delivery systems
• MDCG 2024-1-3: DSVG 03 : Cardiac Implantable Electronic Devices (CIEDs)
• MDCG 2024-1-4: DSVG 04 : Breast implants