Uuringumeditsiiniseadme tootja peab vastavushindamisel järgima paragrahvides 204–212 kirjeldatud protseduuri «Eriotstarbelisest meditsiiniseadmest teavitamine» ja paragrahvides 213–224 kirjeldatud protseduuri «Kliiniline uuring ja kliiniline hinnang».
Meditsiiniradioloogia protseduuri teostav arst (radioloog või radioloogilt volituse saanud teise eriala arst) vastutab peale protseduuri põhjendatuse ka ... samuti protseduuri tulemuse kliinilise hindamise eest ...
Clinical evaluation 1. General provisions. 1.1. As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I under the normal conditions of use of the device and the evaluation of the undesirable side-effects must be based on clinical data in particular in the case of implantable devices and devices in Class III.
Clinical Responsibility: responsibility regarding individual medical exposures attributed to a practitioner, notably: justification; optimization; clinical evaluation of the outcome; cooperation with other specialists and the staff, as appropriate ...
