EU - MDCG publishes templates and first cases of Device Specific Vigilance Guidances
MDCG 2024-1 contains a template for Device Specific Vigilance Guidances (DSVG). Concrete guidande documents will bear an additional ongoing number (MDCG 2024-1-X). The first four DSVGs address (comparable to their MEDDEV predecessors) cardiac ablation, coronary stents, cardiac implantable electronic devices (CIEDs) and breast implants.