Module 15 Presentations

10/04/2024

Types of Clinical Studies

The Organisation for Professionals in Regulatory Affairs

3

Types of Clinical Studies

Clinical Investigations generally fit into 2 main categories

Studies conducted Pre-CE Mark

Studies conducted Post CE-Mark

Previously the MDD, AIMDD and ISO14155 mainly provided guidance for Clinical Investigations of Pre-CE Marked devices

The Organisation for Professionals in Regulatory Affairs

4