Module 15 2022

19/05/2022

Identify the clinical data

State of the art: “Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes and patient management, based on the relevant consolidated findings of science, technology and experience”. Note: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of the-art does not necessarily imply the most technologically advanced solution.

Sources: Definition IMDRF/GRRP WG/N47, MDCG 2020-6

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

25

Identify the clinical data

Data for the state of the art - objectives:

● Describe the clinical field ● Identify potential clinical hazards ● Support equivalence ● Support the validity of surrogate endpoints ● Identify parameters used for the risk benefit determination

Benchmarking based on data on similar devices

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

26

13