IVDR 2025 Update: New Guidance Tightens Change Control for Companion Diagnostics
November 2025 — In a move to clarify regulatory expectations under the In Vitro Diagnostic Regulation (EU IVDR 2017/746), Team-NB has released an updated Position Paper (Version 2, dated 22 October 2025), significantly impacting how Companion Diagnostic (CDx) manufacturers approach product changes. This guidance sharpens the focus on Annex IX, Section 5.2 of the IVDR, […]
Navigating IEC 62304: A Comprehensive Guide to Medical Device Software Lifecycle Compliance
INTRODUCTION: WHY SOFTWARE & REGULATION MATTER In today’s digital healthcare landscape, software has become central to the functionality and safety of medical devices. From diagnostic tools to monitoring systems, the performance of medical device software can significantly impact patient outcomes. This makes regulatory compliance not just a legal requirement but a matter of patient safety […]
Medical Devices Sector Applauds Government’s Withdrawal of QCOs on Essential Raw Materials
New Delhi, November 19, 2025 – In a landmark move welcomed across industries, the Government of India has officially withdrawn multiple Quality Control Orders (QCOs) on key raw materials critical to the medical devices sector. This policy shift, notified in the Gazette on November 12, 2025, is expected to significantly ease regulatory bottlenecks and boost […]
A Guide to MDCG 2025-8 for Spectacle Frames, Lenses, and Reading Glasses
WHAT IS THE MASTER UDI-DI AND WHY IS IT IMPORTANT? The Master UDI-DI is a regulatory solution designed to reduce the burden of UDI management for medical devices that come in a large number of variants. As outlined in the EU MDR 2017/745, each medical device placed on the EU market requires a Basic UDI-DI […]