Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1) (‘PMPF study’), and where the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 69.
I gcás ina bhfuil staidéar feidhmíochta le déanamh chun measúnú breise a dhéanamh, laistigh de raon feidhme na críche a beartaíodh di, ar fheiste a bhfuil an mharcáil CE uirthi cheana féin i gcomhréir le hAirteagal 18(1) (“Staidéar MLFI”) agus i gcás ina mbeadh sé i gceist le staidéar feidhmíochta ábhair a chur faoi ghnáthaimh sa bhreis orthu siúd a dhéantar faoi ghnáthdhálaí úsáide na feiste agus ina bhfuil na gnáthaimh sin ionrach nó ina gcuireann ualach breise ar na hábhair, tabharfaidh an t-urraitheoir fógra do na Ballstáit lena mbaineann ar a laghad 30 lá sula gcuirfear tús leis trí bhíthin an chórais leictreonaigh dá dtagraítear in Airteagal 69.