FDA ADVANCES REAL-WORLD EVIDENCE IN DRUG & DEVICE REVIEWS
United States, December 15, 2025, the FDA has officially removed a massive roadblock for medical device manufacturers. The agency announced a “common-sense reform” that changes how companies can use Real-World Evidence (RWE) to get products approved. For years, manufacturers wanted to use large, real-world databases to prove their devices worked. But the FDA had a […]
MDCG 2025-9 Published: The EU Finally Gets Its “Breakthrough Device” Pathway
December 2025 – The wait is finally over. The Medical Device Coordination Group (MDCG) has published MDCG 2025-9, officially introducing a dedicated Breakthrough Device (BtX) pathway for Europe. For years, manufacturers have looked enviously at the US FDA’s Breakthrough Devices Program while navigating the complex and often slower timelines of the EU MDR/IVDR. This new […]
CDSCO Form MD-26 and MD-27: A Step-by-Step Guide for Medical Device Importers
INTRODUCTION If you are looking to bring a brand-new medical device into India one that doesn’t have a “predicate” (a similar device already on the market) you might feel like you’ve entered a maze of forms and acronyms. You have probably heard of Form MD-26 and Form MD-27, but did you know there is often […]
Risk Management under EU MDR
RISK MANAGEMENT FOR EU MDR COMPLIANCE EU MDR 2017/745 requires medical device manufacturers to manage risks systematically to ensure patient and user safety. Article 10 of the MDR makes it mandatory to establish and maintain a risk management system throughout the entire life cycle of the device from design and manufacturing to post-market use. This […]
NEW EUDAMED UDI/DEVICES USER GUIDE RELEASED
Europe, 15 December 2025 — The European Commission has released an updated UDI Devices User Guide v 3.22.0 for the EUDAMED UDI/Devices module. This document serves as the definitive manual for manufacturers (MFs) and system/procedure pack producers (SPPPs) to ensure their product information is correctly registered and available to the public. This guide outlines the […]
Draft Notification: Indian Medical Device Rules Amended
India, 15 December 2025 The Ministry of Health and Family Welfare (MoHFW) has formally published a Draft Notification (G.S.R. 883(E)) proposing significant amendments to the Medical Devices Rules, 2017. The draft was published in the Gazette of India on December 4, 2025. These amendments aim to simplify business operations by introducing perpetual license validity while […]