Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Source examples Clinical Performance: Published experience gained

• Data from evaluation or re-evaluation by competent authorities (e.g. ANSM in France) • Data from accreditation (laboratory validation data) • Proficiency data report / external quality assurance data (e.g. independent medical and/or laboratory associations such as WHO or IFCC) • Data from post launch studies (after CE marking), incl. PMPF & PMS data • Data from Investigator initiated studies • Data from Real World Evidence (generated during routine clinical use) • Data from Health Economics and Outcome Research (HEOR) studies

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Step 3: Document

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