Module 15 2022
19/05/2022
Key Definitions for Clinical Evaluation
The Organisation for Professionals in Regulatory Affairs
Module 15 Lecture 2
3
MDR Key Definitions for Clinical Evaluation Definition MDD Article 1.2 MEDDEV Section 4 MDR Article 2
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
Made with FlippingBook Digital Publishing Software