In the case of implantable devices and class III devices, clinical investigations shall be
performed, except if:
— the device has been designed by modifications of a device already marketed by
the same manufacturer,
— the modified device has been demonstrated by the manufacturer to be
equivalent to the marketed device, in accordance with Section 3 of Annex XIV
and this demonstration has been endorsed by the notified body, and
— the clinical evaluation of the marketed device is sufficient to demonstrate
conformity of the modified device with the relevant safety and performance
requirements.
In this case, the notified body shall check that the PMCF plan is appropriate and
includes post market studies to demonstrate the safety and performance of the device.
In addition, clinical investigations need not be performed in the cases referred to in
paragraph 6…
