In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification.
Sa chás sin, sonrófar sa phlean don staidéar ar fheidhmíocht chliniciúil dá dtagraítear i Roinn 2.3.2. de Chuid A d'Iarscríbhinn XIII cathain a thiocfaidh na torthaí ar an staidéar feidhmíochta chun bheith ar fáil, maille le bonn cirt.