Member States shall assess whether the performance study is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected.
Déanfaidh na Ballstáit measúnú an mbeidh an staidéar feidhmíochta deartha ar bhealach go mbeidh bonn cirt, tar éis íoslaghdú riosca, leis na rioscaí ionchasacha a bheidh fágtha d'ábhair nó do thríú páirtithe, nuair a mheastar iad i bhfianaise na sochar cliniciúil a mbeifí ag súil leo.