Medical Device Coordination Group (MDCG) has published new guidance on the vigilance system for CE-marked devices

Latest MDCG publication regarding vigilance system and device specific vigilance guidance (DSVG) template for different products.

MDCG 2024-1 Device Specific Vigilance Guidance Template
MDCG 2024-1-1 Cardiac ablation template
MDCG 2024-1-2 Coronary stents template
MDCG 2024 1-3 Cardiac implantable electronic devices (CIEDs) template
MDCG 2024-1-4 Breast implants template

Reach out to EUMEDIQ when you need support in implementing an effective vigilance (software-based) system and/or assessing your current process and see more details here.