EU regulatory seminar for digital medical products

Vogel Professional Education will host a seminar on October 13 and 14 focused on the successful approval of digital medical products within the European Union regulatory framework. Expert Dr. Frank Stein notes that manufacturers of digital, AI-supported medical products must navigate a complex landscape of regulations.

Key requirements include the EU MDR 2017/745, EU IVDR 2017/746, the AI Act, regulations regarding the European Health Data Space (EHDS), cybersecurity requirements, and specific rules for digital health applications (DiGA). The seminar aims to help manufacturers synchronize these various requirements and resolve potential contradictions in the regulatory process.