Agenda
Timings are in BST (London)
-
Introduction to the EU Medical Devices Framework
1.Introduction to Regulation (EU) 2017/745 on Medical Devices (MDR)
- Scope
- Roles
- Exemptions
Break 10 mins
2.EU MDR Essentials: Part 1
- Intended use & classification
- Safety & performance requirements
- Clinical evaluation
Break 10 mins
3.EU MDR Essentials: Part 2
- Technical documentation
- Device & manufacturer registration
- Conformity assessment
Break 15 mins
4.EU MDR Essentials: Part 3
- Post-market surveillance & vigilance
- Transition periods & compliance deadlines
- Additional guidance & support resources
Q&A 10 mins
-
Finish
