Blogs

Introduction: Why Clinical Trials Have Become a Bottleneck for CE Marking For many medical device manufacturers, CE marking under the EU MDR has become slower, costlier, and far more uncertain than under the old MDD....

In 2025, the Medical Device Coordination Group (MDCG) released MDCG 2025-9, a new guidance introducing a structured EU framework for Breakthrough Devices (BtX) under EU MDR (2017/745) and IVDR (2017/746). EU MDCG Guidance Page This...

The Central Drugs Standard Control Organisation (CDSCO) has released a new circular announcing the launch of the Risk Classification Module on the Online Medical Device System (OMDS). https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM2Njc= This update is an important step toward...