Module 15 2022

19/05/2022

Clinical Evaluation Plan

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

19

Clinical Evaluation Plan – Annex XIV Part A

Minimum requirements: ● Identification of relevant GSPRs ● Specification of the intended purpose of the device ● Clear specification of intended target groups (indications/contraindications) ● Detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters ● Specification of the methods to be used for examination of qualitative and quantitative aspects of clinical safety with a clear reference to the determination of residual risks and side-effects

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

20

10