Introduction to the EU Medical Devices Framework

• Introduction to Regulation (EU) 2017/745 on Medical Devices (MDR)
  • Scope
  • Roles
  • Exemptions
• EU MDR Essentials: Part 1
  • Intended use & classification
  • Safety & performance requirements
  • Clinical evaluation

Break 10 minutes

• EU MDR Essentials: Part 2
  • Technical documentation
  • Device & manufacturer registration
  • Conformity assessment
• EU MDR Essentials: Part 3
  • Post-market surveillance & vigilance
  • Transition periods & compliance deadlines
  • Additional guidance & support resources