When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR.
According to section 2 of Chapter I of Annex XV of the MDR, clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge, and defined in such a way to be able confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to the benefit-risk determination of devices. The clinical investigation shall include an adequate number of observations to guarantee the scientific value and validity of the conclusions. The procedures and research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation.
Section 3 of Chapter II of Annex XV of the MDR describes the legally required content of the Clinical Investigation Plan (CIP). Further the sections 2.7 in chapter I, 3.12 chapter II as well as 4 and 6 in chapter III of Annex XV indicate that clinical investigations should be conducted in accordance with good clinical practice.
MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
MDCG 2024-3 - Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
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