This episode delves into the EU's new Artificial Intelligence Act and its significant impact on medical device manufacturers. We explore the "high-risk" classification for most AI-driven medical devices, the new compliance obligations that run parallel to existing MDR/IVDR requirements, and the critical timelines manufacturers must meet. We break down the challenges and strategies for navigating this dual regulatory framework, from data governance to human oversight.

- What is the EU AI Act and why is it critical for MedTech companies?

- How are AI-powered medical devices classified under this new regulation?

- What are the new, specific compliance requirements beyond MDR and IVDR?

- How does the conformity assessment process work for both the AI Act and MDR/IVDR?

- Are you required to get two separate certifications?

- What is the key compliance deadline that all manufacturers must have on their calendar?

- How should you prepare your Quality Management System and technical documentation for this dual framework?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI tools. We act as your local representative in over 30 markets, developing efficient regulatory strategies to get your products approved faster. Our AI-powered platforms help compile and manage technical dossiers for seamless submissions to authorities in the EU and beyond. Whether you're a startup or a multinational, we provide tailored solutions for market access and continuous compliance. Contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and database at https://pureglobal.ai.