MDCG Guidance

Guidance – MDCG endorsed documents and other guidance 

• MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
• MDCG 2023-3 rev.2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
• MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template
• MDCG 2024-1-1 DSVG 01 on Cardiac ablation
• MDCG 2024-1-2 DSVG 02 on Coronary stents
• MDCG 2024-1-3 DSVG 03 on Cardiac implantable electronic devices (CIEDs)
• MDCG 2024-1-4 DSVG 04 on Breast implants
• MDCG 2024-1-5 DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence