Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Intended Purpose and Clinical Performance

Art. 2.41. ‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;

Scientific Validity

Commercial Implications

Clinical Performance

About all elements of the Intended Purpose will have an impact on the Clinical Performance to established.

Intended Purpose

… and on the Clinical Performance Studies

Risk Management

Classification

Liability

www.qarad.com

Slide 17 of 58

17

Intended Purpose and Clinical Performance

• The clinical condition: how detailed? • Fairly clear but do not try to be comprehensive.You would have to provide evidence for all the listed clinical conditions • An example for aldosterone: • Too vague, not really associated with a condition: “Aldosterone measurements are useful to identify excessive or deficient levels of aldosterone.” • Too detailed: “Aldosterone measurements are useful to aid in the diagnosis of adrenal hyperplasia, adrenal adenoma, adrenal carcinoma, massive ascites, ventricular failure, cor pulmonale, proximal renal tubular acidosis, fibromuscular dysplasia, excessive licorice intake, etc., etc.” • Better: “Aldosterone measurements are useful to aid in the diagnosis of conditions associated with primary or secondary hyperaldosteronism (e.g., congenital adrenal hyperplasia) or with primary or secondary hypoaldosteronism (e.g., primary adrenal insufficiency).”

www.qarad.com

Slide 18 of 58

18