Latest industry news and developments
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.
The US Food and Drug Administration (FDA) updated list of of authorised AI/ML-Enabled Medical Devices. This marks a significant 37% increase from last year (692 devices). The majority of the approved devices (750 out of 950) are designated for radiology, with cardiology following at 98 devices and neurology at 34. The FDA emphasizes that the list isn't exhaustive but covers AI/ML devices across medical disciplines based on marketing authorization document summaries.
We are excited to announce that MDR Regulator has joined the AI in Health Coalition as a supporting member! Our involvement in this coalition signifies our commitment to advancing the integration of artificial intelligence in healthcare. We look forward to collaborating with other industry leaders to drive innovation and improve patient outcomes.
On July 16th, an exceptional webinar organized by Izba Polmed and our partners: MedTech Polska, AI w Zdrowiu, MDR Regulator, and Pure Clinical took place. The turnout was fantastic, and we thank all participants for their active involvement!
On 12 July 2024, regulation (EU) 2024/1689 was issued, introducing a regulatory framework for artificial intelligence (AI), the AI Act. The publication came more than three years after the European Commission published the proposed original text in April 2021. The AI Act aims to promote trustworthy AI while ensuring a high level of protection for health, safety and fundamental rights of the EU. The document defines requirements for AI systems according to the level of risk posed and imposes obligations on providers placing on the market or putting into service AI systems.
