The sponsor conducting a performance study in Slovenia must notify the JAZMP of the study’s conclusion within 15 days of its completion.
Within one year of the end of the performance study, the sponsor must submit a performance study report to the JAZMP, as referred to in Section 2.3.3 of Part A of Annex XIII to the IVDR. If the performance study was temporarily halted or terminated early, the performance study report must be submitted to the JAZMP within three months of the temporary halt or early termination. The performance study report must be accompanied by a summary written in a way that is easily understandable to the intended user.
Until the EUDAMED modules are fully functional, sponsors must submit this notification either in person at the JAZMP head office or by post to the following address: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), Slovenčeva ulica 22, 1000 Ljubljana, together with the case number assigned to their application for the performance study.
