Module 15 Presentations

10/04/2024

Key Definitions for Clinical Evaluation

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

3

MDR Key Definitions for Clinical Evaluation MDR Article 2 MEDDEV Section 4 MDD Article 1.2 Definition

Intended purpose

(g)

(12) Link to IFU/materials and CER



Clinical evaluation

Annex X

(44) Clinical Benefit, continuous



Clinical investigation

-

(45) similar



Clinical Data

(k)

(48) Includes PMS/PMCF



Clinical Evidence

-

(51) Sufficient Quantity and quality



Sufficient Clinical Evidence

-

-



Performance

-

-

(22) New

Clinical Performance

-

(52) Leads to clinical benefit



Clinical benefit

-

-

(53) New

Benefit-risk determination

-

-

(24) New

Equivalence

-

Annex A1

Annex XIV

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

4

2