Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

• Classification as Class C reflects the high level of risk to the patient should the device generate erroneous results • Relevant performance characteristics for a CDx are the same as other IVDs: • scientific validity / rationale e.g. what is evidence that the biomarker predicts drug response? • analytical performance data e.g. can the IVD correctly detect / measure the biomarker? • clinical performance data e.g. do the results correlate with drug response in the target population? • These data form an essential part of the clinical evidence that the intended clinical benefits (related to function as CDx) and safety of CDx will be achieved IVDR: summary of CDx requirements (1)

The Organisation for Professionals in Regulatory Affairs

11

• Clinical performance studies required for CDx unless otherwise justified, to demonstrate: • the clinical benefit e.g. that the test can identify patients for whom a corresponding medicine is safe and effective • that the device is safe • Before conducting interventional clinical performance studies or those involving CDx (article 58): • submit application to relevant Devices Competent Authority(ies) to obtain prior authorisation • include data to support scientific validity (or rationale) and analytical performance • also applies to CE-marked devices used outside scope of intended purpose Performance studies

The Organisation for Professionals in Regulatory Affairs

12

6