Latest industry news and developments
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.
Team NB has released an updated version of the Code of Conduct for Notified Bodies, introducing key changes in line with current EU regulations on medical and diagnostic devices. The new version focuses on harmonizing operations, increasing transparency in certification processes, and enhancing oversight of product safety.
In accordance with Article 50 of Regulation (EU) 2017/745 on medical devices and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, notified bodies establish lists of their standard fees for the conformity assessment activities that they carry out and make those lists publicly available.
