The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies conducted outside the Union in accordance with international guidelines to be accepted within the Union.
Ba cheart na rialacha maidir le staidéir feidhmíochta a bheith i gcomhréir leis an treoir idirnáisiúnta seanbhunaithe sa réimse seo, amhail caighdeán idirnáisiúnta ISO 14155:2011 maidir le dea-chleachtas cliniciúil i gcás imscrúduithe cliniciúla ar fheistí leighis lena n-úsáid ag an duine, le gur fusa a bheidh sé na torthaí ar staidéir feidhmíochta a dhéanfar san Aontas a ghlacadh mar dhoiciméadacht lasmuigh den Aontas agus le gur fusa a bheidh sé torthaí na staidéar feidhmíochta sin a dhéanfar lasmuigh den Aontas i gcomhréir le treoirlínte idirnáisiúnta a ghlacadh laistigh den Aontas.