The rules on clinical investigations 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 clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union.
Ba cheart na rialacha maidir le himscrúduithe cliniciúla a bheith i gcomhréir leis an treoir idirnáisiúnta sheanbhunaithe sa réimse sin, amhail Caighdeán Idirnáisiúnta ISO 14155:2011 maidir le dea-chleachtas cliniciúil i gcás imscrúduithe cliniciúla ar fheistí leighis lena n-úsáid ag daoine, le gur fusa a bheidh sé lasmuigh den Aontas glacadh leis na torthaí ó imscrúduithe cliniciúla a dhéantar san Aontas mar dhoiciméadacht agus le gur fusa a bheidh sé laistigh den Aontas glacadh leis na torthaí ó imscrúduithe cliniciúla a dhéantar lasmuigh den Aontas i gcomhréir le treoirlínte idirnáisiúnta.