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 as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions.
Déanfar imscrúduithe cliniciúla ar bhonn plean iomchuí imscrúdaithe ina léireofar an saineolas eolaíoch agus teicniúil is déanaí agus sonrófar na himscrúduithe sa dóigh is go ndeimhneoidh nó go ndiúltóidh siad éilimh an mhonaróra maidir le sábháilteacht na feiste, a feidhmíocht agus na gnéithe sin a bhaineann le tairbhe-riosca na bhfeistí amhail dá dtagraítear in Airteagal 62(1); áireofar sna himscrúduithe cliniciúla dóthain breathnuithe chun bailíocht eolaíoch na gconclúidí a ráthú.