Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation.
Na feistí sin atá comhdhéanta de shubstaintí nó de theaglamaí substaintí a beartaíodh lena dtabhairt isteach i gcorp an duine, agus a ionsúitear i gcorp an duine nó a scaiptear go logánta i gcorp an duine, comhlíonfaidh siad, i gcás inarb infheidhme agus ar bhealach atá teoranta do na gnéithe nach gcumhdaítear faoin Rialachán seo, na ceanglais ábhartha a leagtar síos in Iarscríbhinn I a ghabhann le Treoir 2001/83/CE maidir le meastóireacht a dhéanamh ar ionsú, ar dháileadh, ar mheitibiliú, ar eisfhearadh, ar fhulaingt logánta, ar thocsaineacht, ar idirghníomhaíocht le feistí eile, le táirgí íocshláinte nó le substaintí eile agus ar an mbaol a d'fhéadfadh a bheith ann go dtarlódh frithghníomhartha díobhálacha, mar a cheanglaítear leis an nós imeachta um measúnú comhréireachta is infheidhme atá faoin Rialachán seo.