Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.
Déanfaidh monaróirí meastóireacht chliniciúil i gcomhréir leis na ceanglais a leagtar amach in Airteagal 61 agus in Iarscríbhinn XIV, lena n-áirítear MLCI.