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Ukuqeqeshwa kwe-Hitec Medical MDR - EzobuchwephesheDi-ocumentationRIzidingo ezingaphansi kwe-MDR(Ingxenye 2)

Izidingo zokuhlolwa komtholampilo ngaphansi kwe-MDR

Ukuhlolwa komtholampilo: Ukuhlolwa komtholampilo ukuqoqwa, ukuhlolwa, nokuhlaziywa kwedatha yomtholampilo ngokusebenzisa indlela eqhubekayo nenamandla, kusetshenziswa idatha eyanele yomtholampilo ukuze kunqunywe ukuthotshelwa kwezidingo ze-GSPR ezifanele.

Uphenyo lomtholampilo: Yenza inhlolovo ehlelekile yamasampula abantu ukuze uhlole ukusebenza nokuphepha kwamadivayisi ezokwelapha.

I-PMS: Ukubhekwa kwemakethe yeposi:Kubhekiselwa kuyo yonke imisebenzi eyenziwa abakhiqizi nabanye abaqhubi bezomnotho ngokubambisana, ngenhloso yokusungula nokugcina izinqubo zakamuva zokuqoqa nokufingqa ulwazi olutholwe emishinini eyethulwe futhi etholakalayo noma esetshenziswa emakethe, futhi inqume ukuthi izinyathelo ezidingekayo zokulungisa nezokuvimbela zidinga ukuqondwa.

I-PMCF: Ukulandelela komtholampilo kwe-post market:Indlela nenqubo yokuqoqa nokuhlola idatha yomtholampilo ngokusebenza nokuphepha kwedivayisi.Njengengxenye yemibhalo yezobuchwepheshe, i-PMCF ixhunywe futhi isetshenziselwe ukubuyekeza uhlelo lwe-PMS kanye ne-CER.Ingasetshenziswa futhi njengesifanekiso semibiko ye-PMCF.

I-Athikili ye-MDR 10:Abakhiqizi bazohlola umtholampilo ngokuhambisana nezidingo ze-Athikili 61 kanye neSithasiselo XIV, okuhlanganisa ukulandelelwa komtholampilo kwangemuva kwemakethe ye-PMCF.

I-Athikili ye-MDR 61: Ukuqinisekiswa kokuthobelana nezidingo eziyisisekelo zokuphepha nokusebenza kufanele kusekelwe kudatha yomtholampilo, kanye nedatha evela ku-PMS yokubhekwa kwemakethe yangemuva.Abakhiqizi kufanele benze ukuhlolwa kwemitholampilo ngokohlelo bese benza imibhalo ebhaliwe.

I-Athikili ye-MDR 54:Kumadivayisi athile e-Class III kanye ne-IIb, indikimba eyazisiwe izosebenzisa inqubo yokubonisana yokuhlolwa komtholampilo:

Amadivayisi afakelwayo we-Class III

I-IIb amadivayisi asebenzayo akhishwa emzimbeni womuntu noma anikezwe umzimba womuntu ngendlela engaba yingozi.

Izimo ezilandelayo azidingi inqubo yokubonisana nokuhlolwa komtholampilo:

1. Ukuvuselela izitifiketi ngokuhambisana nemithetho ye-MDR;
2. Ukuguqulwa kwemikhiqizo kakade emakethe ngumkhiqizi ofanayo.Lokhu kuguqulwa akuthinti isilinganiso sengozi yenzuzo yedivayisi;
3. Kukhona ama-CS afanelekile futhi indikimba eyazisiwe iqinisekise ukuthobela isigaba sokuhlolwa komtholampilo ku-CS.