where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
i gcás ina dtugtar aghaidh ar na prionsabail maidir le meastóireacht chliniciúil chineál nó chatagóir na feiste in SCanna dá dtagraítear in Airteagal 9 agus go ndeimhníonn an comhlacht dá dtugtar fógra go bhfuil meastóireacht chliniciúil an mhonaróra maidir leis an bhfeiste sin i gcomhréir le SCanna ábhartha maidir le meastóireacht chliniciúil ar fheiste den sórt sin.