Latest industry news and developments
The year 2024 has been a time of intensive changes and challenges for the medical device and in vitro diagnostics (IVD) industries. As active participants in these sectors, we had the opportunity to witness and contribute to key events that shaped the future of the market and regulatory standards.
The certification of medical devices under MDR is a multi-step process requiring thorough preparation and collaboration with Notified Bodies. Explore the key stages outlined in the Team-NB consensus document to streamline your certification journey.
The Warsaw Medical Expo has come to an end, marking another successful event for MDR Regulator. Our presence at the trade fair provided an opportunity to showcase our expertise in regulatory consulting, clinical trials, and market commercialization on a global scale.
On November 26, 2024, the FDA published guidance on its transitional enforcement policy for changes in ethylene oxide (EtO) sterilization facilities for Class III medical devices. The policy aims to prevent potential disruptions in the supply chain of sterile medical devices while sterilization facilities adapt to updated Environmental Protection Agency (EPA) requirements.
The Artificial Intelligence in Medical Devices Questionnaire, developed by Team-NB and IG-NB, is an essential guideline designed to align AI-based medical devices with the requirements of the MDR and IVDR. This document provides process-oriented recommendations for manufacturers, focusing on safety, performance, and regulatory compliance throughout the lifecycle of AI-based medical devices.
MEDICA 2024 has concluded, and it was an incredible experience for our team at MDR Regulator. The world’s largest medical technology fair provided a unique platform for discussions, networking, and sharing knowledge with industry leaders from around the globe.
In October 2024, the European Commission introduced a new Q&A guidance document on Article 10a of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) through Regulation (EU) 2024/1860.
Team-NB emphasizes the importance of streamlining regulatory processes, supporting small and medium-sized enterprises (SMEs), and maintaining efficient certification timelines to uphold EU medical device safety standards.
On October 29, the Medical Device Coordination Group (MDCG) published an updated guidance document, "MDCG 2022 – 5 Rev. 1," which provides essential updates for categorizing borderline products.
