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
- Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence (Published in June 2024)
You can read these and other relevant MDCG Guidances in our MDCG section in MDlaw!
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