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

Kamelija Milosev

Subject Matter Expert - Chemicals, Enhesa