It is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on scientific validity, and the analytical performance and clinical performance of the device.
Ní mór na ceanglais maidir le léiriú na fianaise cliniciúla a shoiléiriú, ar cheart di bheith bunaithe ar shonraí maidir le bailíocht eolaíoch, agus feidhmíocht anailíseach agus feidhmíocht chliniciúil na feiste.