Newly Published MDCG Guidance documents on Vigilance System under (EU) 2017/745 Medical Devices Regulation
Within the scope of (EU) 2017/745 Medical Devices Regulation (MDR), five new MDCG Guidance documents on the vigilance system of CE-marked devices have been published on the EU Commission's website on 30th January 2024. This new guidance aims to harmonize vigilance reporting and provide guidance for manufacturers of specific devices.
You can access the abovementioned MDCG guidance using the links below:
1- MDCG 2024-1 Guidance on the vigilance system for CE-marked devices DSVG 00 Device Specific Vigilance Guidance (DSVG) Template
https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf
2- MDCG 2024-1-1 Guidance on the vigilance system for CE-marked devices DSVG 01 Devices for Cardiac Ablation
https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf
3- MDCG 2024-1-2 Guidance on the vigilance system for CE-marked devices DSVG 02 Coronary Stents and associated delivery systems
https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf
4- MDCG 2024-1-3 Guidance on the vigilance system for CE-marked devices DSVG 03 Cardiac Implantable Electronic Devices (CIEDs)
https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf
5- MDCG 2024-1-4 Guidance on the vigilance system for CE-marked devices DSVG 04 Breast Implants
https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf