In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the investigational device and of the scientific design of that clinical investigation, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State.
Chun gur féidir acmhainní a roinnt agus chun comhsheasmhacht a áirithiú maidir le measúnú ar na gnéithe sláinte agus sábháilteachta den fheiste imscrúdaitheach agus de dhearadh eolaíoch an imscrúdaithe chliniciúil sin, ba cheart an nós imeachta chun measúnú a dhéanamh ar iarratas aonair den sórt sin a chomhordú idir na Ballstáit faoi stiúir Ballstát comhordaithe.