Clinical Performance Study Management for In Vitro Diagnostic Devices according to IVDR
Clinical Performance Study Management for In Vitro Diagnostic Devices according to IVDR
The clinical evaluation of a device should be performed through a clinical performance study that will be performed in accordance with the ISO 20916:2019 In Vitro Diagnostic Medical Devices - Clinical Performance Studies Using Specimens From Human Subjects - Good Study Practice. These studies should be performed after obtaining an Internal Review Board approval. In order to apply for approval of such as study, the application forms should accompany Clinical Performance Study Plan and Investigator’s Brochure.
Clinical performance studies should be performed on the basis of a clinical performance study plan (CPSP). The CPSP should clearly define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct, and record-keeping of the clinical performance study as explained in Annex XIII of the IVDR.
The investigator's brochure (IB) shall contain the information on the device for performance study that is relevant for the study and available at the time of application.
Performance studies should be subjected to scientific and ethical review. The requirements for Ethics Committee Applications vary depending on the national regulations and the specific requirements of the IRB Committee where the clinical performance study will be conducted. Nevertheless, it is mentioned in the IVDR that Member States should ensure the involvement of at least one layperson, in particular patients or patients' organisations and that the necessary expertise is available in the Ethics Committees.
The ethical review shall be performed by an ethics committee in accordance with national law. The Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorization of a performance study. Each Member State has designated a Competent Authority that oversees the Ethics Committee Applications. Following approval by the local IRB, an application should be submitted to the corresponding National Competent Authority. The study can be started after obtaining approval from the National Competent Authority.
Clinical performance studies shall be designed in such a way as to maximize the relevance of the data while minimising potential bias. After being approved by both the local IRB and the National Competent Authority, the clinical study should be performed in accordance with the relevant CS or harmonized standards and Good Clinical Practice.
The clinical performance study report shall, while taking into account applicable CS or harmonised standards, examine in particular the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study, and methodological aspects, including sample size, comparator, and endpoints.
As per Annex XIII Section 2.3.3 of the IVDR, the Clinical Performance Study Report (CPSR) should be signed by a medical practitioner or any other authorized person responsible and contain documented information on the clinical performance study protocol plan (CPSP), and results and conclusions of the clinical performance study, including negative findings. It is imperative that the results and conclusions are presented transparently, free of bias, and clinically relevant. The CPSR shall contain sufficient information to enable it to be understood by an independent party without reference to other documents and include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale.
