Medical device CE marking

MDCG issues 1 template and 5 guidances on device specific vigilance


The MDCG issued 4 device specific guidances on the vigilance system for CE-marked devices:

  • MDCG 2024-1-1DSVG 01: Devices for Cardiac Ablation
  • MDCG 2024-1-2DSVG 02: Coronary Stents and associated delivery systems
  • MDCG 2024-1-3 – DSVG 03: Cardiac Implantable Electronic Devices (CIEDs)
  • MDCG 2024-1-4 – DSVG 04: Breast Implants 
  • MDCG 2024-1-5 – DSVG 05: Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence

And also a template:

  • MDCG 2024-1DSVG 00: Device Specific Vigilance Guidance (DSVG) Template

The documents can be downloaded in our library (see links above)

Source: European Commission