EU Supply Chain Alert: Navigating Medical Device Shortage Notifications Under Regulation 2024/1860

This episode unpacks the critical amendments introduced by Regulation (EU) 2024/1860, focusing on the new obligations for medical device manufacturers to notify authorities about supply interruptions and discontinuations. We explore why this has become a major compliance challenge, touching on its impact on portfolio management, distributor relations, and the necessity for early risk detection systems to prevent shortages and ensure market stability in the European Union. - What are the new supply shortage notification rules under EU Regulation 2024/1860? - When must a manufacturer inform authorities about discontinuing a medical device? - Why is supply continuity now a major compliance hotspot in the EU? - How does this regulation affect your product portfolio and end-of-life planning? - What systems should you have in place to flag potential supply interruptions early? - How should communication with distributors be managed in light of these new rules? - What are the potential consequences of failing to comply with these notification requirements? Navigating complex regulations like the EU's new supply continuity rules is essential for maintaining market presence. Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, ensuring you stay compliant across more than 30 global markets. Our experts develop clear regulatory strategies and use advanced AI to monitor regulatory changes, helping you anticipate challenges and maintain uninterrupted market access. We act as your local representative, handling communications with authorities so you can focus on your business. For support, visit us at https://pureglobal.com, contact [email protected], or explore our FREE AI tools and database at https://pureglobal.ai.