New vigilance system guidelines for CE-marked medical devices MDCG 2024-1
In an effort to standardize the way medical incidents, serious incidents and trend reporting are reported, new MDCG 2024-1 guidelines have been created to provide guidance on specific groups of medical devices. Manufacturers of cardiac ablation devices, coronary stents, implantable cardiac electronic devices and breast implants can consult these guidelines on the European Commission’s website.
In January 2024, a new MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template was created to standardize the way medical incidents, serious incidents and reporting trends are reported.
It is the responsibility of medical device and in vitro diagnostic medical device manufacturers to monitor adverse events, evaluate them and report them to the relevant competent authority. The Medical Devices Coordinating Group has set guidelines for what adverse reactions should be reported as device-related problems, and has specified how to report incidents and serious incidents.
The guidelines were developed for specific groups of medical devices:
- MDCG 2024-1-1 DSVG 01 on Cardiac ablation (cardiac ablation devices).
- MDCG 2024-1-1 DSVG 02 on Coronary stents (coronary stents).
- MDCG 2024-1-1 DSVG 03 on Cardiac implantable electronic devices (CIEDs).
- MDCG 2024-1-1 DSVG 04 on Breast implants (breast implant).
The guidelines for each device list device problems and health effects that should be reported after a single occurrence and when the manufacturer observes an increase in the trend of a particular adverse reaction. It also summarizes all the requirements that manufacturers should meet in vigilance reporting.