Latest industry news and developments
On January, 2024, the IMDRF published guidance on Good Machine Learning Practice (GMLP) for Medical Devices and considerations for medical device software & software-specific risk. These documents provide a framework for ensuring best practices in AI-based medical devices and systematic risk assessment for medical software.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices. These new regulations are critical for manufacturers, distributors, and healthcare professionals to ensure the continued safety and effectiveness of medical devices in the UK.
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.
