Trending Topics: From the AI Act to Orphan Devices, Key Takeaways from RAPS EU Convergence 2024 скачать в хорошем качестве

Trending Topics: From the AI Act to Orphan Devices, Key Takeaways from RAPS EU Convergence 2024

Welcome to our new Trending Topics webinar series! Each webinar in this series will present key trending topics, late-breaking regulatory news and other hot-button topics from medical and in vitro device industry leaders. Tap into the critical conversations that are shaping the future of the MedTech industry and join us as we explore current issues, trending conversations and decisions impacting the MedTech regulatory space. Learning Objectives: In this webinar, we will discuss a few of the key trending topics and issues discussed at the RAPS EU Convergence conference in Berlin. Topics include: 1. The AI Act and MDR: identify the challenges, incompatibilities and conflicts that arise from applying both frameworks to AI-based medical devices. 2. Innovative and Orphan Devices: an expert panel suggests developing MDR special conformity assessment pathways to support the unique regulatory challenges faced by orphan and innovative medical devices. 3. Notified Body Acknowledge Challenges: from inconsistent opinions to EUDAMED delays, notified bodies continue to face numerous challenges in the current regulatory landscape. What can be done? 4. The Impact of “massive procrastination” of MDR and IVDR Dossier Submissions: notified body experts are concerned at the potential constraints to future device availability as applications to the Notified Bodies decline in the wake of deadline extensions. 5. Updates from the IMDRF Working Groups: review the latest updates to the scope and objectives a broad range of guidance documents on topics ranging from artificial intelligence / machine learning (AI/ML), good regulatory review practices, adverse event (AE) terminology, quality management systems, personalized medical devices, and software as a medical device, and discuss their achievements and challenges.