Important Update in EU Medical Device Regulation
MDCG 2024-1-2 Guidance on the Vigilance System for CE-marked Devices (DSVG) 02 Coronary Stents and associated delivery systems. January 2024.
The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Coronary Stents and associated delivery systems. It provides further clarification for vigilance reporting of Coronary Stents and associated delivery systems to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR). This DSVG does not replace or extend any of those requirements. This document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, in accordance with Articles 87 and 88 MDR, which occurred with Coronary Stents and associated delivery systems to the relevant Competent Authority.
Know more about our Post Market Surveillance (PMS) services at https://lnkd.in/dt4tQYNy