Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document (DSVG) to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.
The specific devices are:
MDCG 2024-1-1: DSVG 01 – Cardiac ablation
MDCG 2024-1-2: DSVG 02 – Coronary stents
MDCG 2024-1-3: DSVG 03 – Cardiac implantable electronic devices (CIEDs)
MDCG 2024-1-4: DSVG 04 – Breast implants
Each guidance provides specific device-related examples and what should be reported as:
- Individual serious incidents
- Periodic Summary Reporting
- Trend Reporting
What Does This Mean To You?
MDCG 2024-01 provides insights on the way to report incidents and serious incidents for devices.
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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