Basics of Regulatory Affairs for Start-ups in Medical Technology

Agenda Day 1 (Tuesday, 18.05.2021)

09:15: Welcome by the Organizers

09:20: Introduction – Steps to CE Mark for Medical Devices (Medidee)

• MDR / IVDR
• Medical device classification – conformity assessment
• General safety and performance requirements (GSPR)
• State of the art concept – principle of presumption of conformity
• Role of Notified Bodies and working with Notified Bodies
• Status update – implementation of MDR / IVDR

10:30: V&V and Technical Documentation (Medidee)

• Risk management & usability engineering
• Setting up a design & development process
• From user requirements to design validation
• Design verification and pre-clinical validation
• Technical documentation as evidence for compliance

12:00: Open Q&A (all speakers) - End of Day 1

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Joint Lunch Break (feel free to stay for a chat and exchange your thoughts)

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Agenda Day 2 (Wednesday, 19.05.2021)

09:15: Welcome by the Organizers

09:20: Clinical Evidence (Medidee)

• Clinical data, clinical evaluation and equivalence discussion
• Post market surveillance & post market clinical follow-up

10:30: US Market Access for Medical Devices (Medidee)

• Regulatory framework
• Classification: 510(k), De Novo, HDE, PMA
• FDA medical devices databases
• Pre-submission programme
• Differences between US and EU regulatory frameworks

11:40: Start-up and Regulatory – avoiding pitfalls (Medidee)

• Milestones of a medical device innovation project, a different view

12:00: Open Q&A (all speakers), Closing, Outlook

The Seminar is part of a two-part-series. Part II, "Market Access for MedTech Start-ups", is planned for October 5-6.