Module 17 2024

05/12/2024

Chapters

1 – Scope of the Regulations 2 – Classification

3 – Economic Operators 4 – Registration and UDI 5 – Approved Bodies 6 – Conformity Assessments 7 – Clinical Investigation and Performance Studies 8 – Post-Market Surveillance, Vigilance, Market Surveillance

The Organisation for Professionals in Regulatory Affairs

15

15

Chapters

9* – In vitro Diagnostic Medical Devices (not covered in this presentation) 10 – Software as a Medical Device 11 – Implantable Devices 12 – Other Product Specific Changes 13 – Environmental Sustainability and Public Health Impacts

14 – Alternative Routes to Market 15 – Transitional Arrangements

The Organisation for Professionals in Regulatory Affairs

16

16

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