Paragraph 4 Methods of clinical investigation
Clinical investigations shall—
be performed according to an appropriate plan of investigation which represents the current state of the art and is defined in such a way as to confirm or refute the manufacturer’s claims for the device; and
include an adequate number of observations to guarantee the scientific validity of the conclusions.
The procedures used to perform the investigations shall be appropriate to the device under examination.
Clinical investigations shall be performed in circumstances equivalent to those which would be found in normal conditions of use of the device.
All appropriate features, including those involving the safety and performances of the device, and its effects on patients, shall be examined.
All adverse events shall be fully recorded.
The investigations shall be performed under the responsibity of an appropriately qualified medical specialist, in an appropriate environment.
The medical specialist shall have access to the technical data regarding the device.
The written report, signed by the responsible medical specialist, shall comprise a critical evaluation of all the data collected during the clinical investigation.