Guidance on UG Mesh Implants

The Medical Device Coordination Group (MDCG) has released Device Specific Vigilance Guidance for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. The MDCG is composed of representatives of all European Union Member States and it is chaired by a representative of the European Commission.

The document provides further clarification for vigilance reporting to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices. This DSVG does not replace or extend any of those requirements.

Download the Guidance document.