The Medical Devices Coordination Group (MDCG) has released a new set of guidances on the vigilance systems for CE-marked devices. As such, a template is provided on Device Specific Vigilance Guidance (DSVG), which focuses on the following topics:
- What should be reported, with a focus on individual serious incidents, Periodic Summary Reporting (PSR) and trend reporting
- DSVG examples
- Clinical references and clinical guidelines
- IMDRF terminologies for categorised adverse event reporting
Moreover, the MDCG released several device-specific guidances, focusing on the following categories:
- Devices Cardiac ablation
- Coronary Stents and associated delivery systems
- Cardiac Implantable Electronic Devices (CIEDs)
- Breast Implants
You can read these and other relevant MDCG Guidances in our MDCG section in MDlaw!
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