New MDCG 2024-1 on ‘Guidance on the vigilance system for CE-marked devices and DSVG Templates’

In January 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-1 DSVG 00 on Guidance on the vigilance system for CE-marked devices, with Device Specific Vigilance Guidance (DSVG) Templates on Cardiac ablation (MDCG 2024-1-1 DSVG 01), Coronary stents and associated delivery systems (MDCG 2024-1-2 DSVG 02), Cardiac implantable electronic devices (MDCG 2024-1-3 DSVG 03) and Breast implants (MDCG 2024-1-4 DSVG 04).

For more, see the Commission’s webpage on guidance.