New MDCG Guidance Released: Device-Specific Vigilance Document
New MDCG Guidance Released: Device-Specific Vigilance Document
Friday, 15 March 2024
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.
On February 6th, 2024, 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. This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR and in Article 2(67) and (68) IVDR, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with Specific Devices to the relevant Competent Authority (MDCG 2024-01).
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.
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