New Era of Medical Device Safety: What Egypt’s Strict Vigilance Guideline Means for Manufacturers
Cairo, Egypt, November 2025 – A comprehensive new framework, “The Egyptian Guideline for Medical Device Vigilance System,” is set to dramatically reshape how medical device manufacturers operate in the country, placing rigorous new obligations on companies from pre-market approval to post-market monitoring. The goal of this guidance, issued by the Egyptian Drug Authority (EDA), is […]
POST-MARKET SURVEILLANCE UNDER EU MDR
INTRODUCTION: THE MDR’S CONTINUOUS CHECK-UP You’ve successfully brought a medical device to market. Great! But in the world of the EU Medical Device Regulation (MDR), getting the CE Mark is just the start. The real test begins when your device is actually being used by patients and healthcare professionals. This is where Post-Market Surveillance (PMS) […]