MDCG 2024-1-(1-4) Guidance on the vigilance system for CE-marked devices (DSVG 01-04)
Cardiac Ablation Device/Coronary Stents/CIEDs/Breast Implant (01/2024)
1 February 2024
The Medical Device Coordination Group (MDCG) has recently published five new documents concerning Device Specific Vigilance Guidance (DSVG). The main document “Guidance on the vigilance system for CE-marked devices – DSVG 00 – Device Specific Vigilance Guidance (DSVG) Template” outlines the following types of vigilance reporting for specific types of devices:
- Serious Incidents
- Periodic Summary Reports
- Trend Reporting
The four sub-guidance documents (MDCG-1-(1-4)), established by Article 103 of Regulation (EU) 2017/745, provide examples of what could be submitted under each type of reporting mechanism. E.g., a serious incident that should be reported individually vs. serious incidents compiled under a periodic summary report vs. a trend report.
The following article is based on the MDCG 2024-1-(1-4) and covers the devices:
- Cardiac Ablation Devices, MDCG 2024-1-1 DSVG 01
- Coronary Stents, MDCG 2024-1-2 DSVG 02
- Cardiac Implantable Electronic Devices (CIEDs), MDCG 2024-1-3 DSVG 03
- Breast Implants, MDCG 2024-1-4 DSVG 04
Scope
The Device Specific Vigilance Guidance (DSVG) aims to harmonise vigilance reporting for the above-mentioned devices and offer guidance to manufacturers. It clarifies the way of vigilance reporting (e.g. (serious) incidents) to relevant competent authorities and should be applied in combination with the Regulation (EU)2017/745 on medical devices (MDR). For a detailed list on what and how should be reported, see MDCG 2024-1-(1-4).
Individual serious incidents
All individual serious incidents (Article 2(65) MDR) should be reported to the competent authorities in accordance with Article 87(6) and (7) MDR. This also applies in cases in which it is unclear, without further clarification, whether the incident originates exclusively from the medical device (MD). Reports should be submitted in the MDR given time frames. Further questions on the reporting and the corresponding timeframes can be found in the MDCG 2023-3.
Periodic Summary Reporting (PSR)
Similar serious incidents with the same device or device type and a clarified root cause can be reported in a consolidated way using the periodic summary reports (PSR) based on Article 92(8)(a) MDR. The format, content and frequency should be coordinated with the competent authorities. Until EUDAMED is applicable, competent authorities should follow the MDCG 2021-1 Rev1.
Trending Reporting
Following Article 88 MDR, manufacturer should inform competent authorities on statistically significant increase in the frequency of severe incidents (no serious incidents) or expected undesirable side-effects. As those might change the risk-benefit ratio. For further information please refer to MDCG 2023-3.
