​From MedTech Innovation to Compliant Market Access.                                     

The European Union is preparing a significant update to how notified bodies operate under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The draft Implementing Act on Notified Body procedures , released in December 2025, aims to bring clarity and consistency to the certification process. If you work with notified bodies or navigate MDR and IVDR certification, understanding this draft act is essential. It promises to reshape timelines, quotation

The FDA Quality Management System Regulation (QMSR) is undergoing a significant update, with the new FDA QMSR final rule published in January 2024 and set to take effect on February 2, 2026. This update marks a major shift from the existing 21 CFR Part 820 QMSR, aiming to better align the US FDA’s medical device quality management system requirements with the international ISO 13485:2016 standard. If you are involved in medical device manufacturing or quality assurance, under