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Medical Device Coordination Group (MDCG) has published new guidance on the vigilance system for CE-marked devices
MDCG has issued new guidance on the vigilance system for CE-marked devices, including a device-specific template and four product-specific templates. A short overview of what has been published.
Latest MDCG publication regarding vigilance system and device specific vigilance guidance (DSVG) template for different productw
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
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KEY TAKEAWAY
New Vigilance Guidance and Device-Specific Templates
MDCG has issued new guidance on the vigilance system for CE-marked devices, including the Device Specific Vigilance Guidance (DSVG) template (MDCG 2024-1) along with device-specific templates for cardiac ablation, coronary stents, cardiac implantable electronic devices, and breast implants.
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