Ngo-28 th . Ephreli 2022, uJoyTech uthole ukukhishwa kokuqala kwe-EU MDR kwabaqaphi bengcindezi yegazi elingahlaseli, ungathola imininingwane lapha.
Ngo-2023, othintana naye uJoyTech, oxhumana nabo ama-thermometers kanye nabaqaphi bengcindezi yegazi entsha bonke bavunywa yi-EU MDR.
Yini i-CE (MDR)?
Uma kufika izitifiketi ze-CE, wonke umuntu uyayazi. Cishe yonke imboni inesitifiketi se-CE esihambisanayo. I-MDR yisifinyezo sokulawulwa kwensiza yaseYurophu, okuyisibuyekezo se-CE (MDD) futhi ibeka izidingo eziphakeme ekuphepheni nasekusebenzeni kwamadivayisi wezokwelapha. Siphinde sibize i-CE (MDR).
Uyini umehluko phakathi kwe-CE (MDD) ne-CE (MDR)?
I-MDR ngumthethonqubo futhi i-MDD iyisiqondiso. Ngoba kungukuthuthuka, okuvela kwimiyalo emithethweni, izifundazwe ze-EU zizosebenzisa ukulawula okuqinile kwenqubo yokuqinisekisa kanye nemiphumela.
Ikakhulukazi kuboniswa ezintweni ezilandelayo:
1) waqinisa izibopho zomkhiqizi.
a) Umkhiqizi kufanele okungenani abe nesikhulu esithile sokuhambisana nobuchwepheshe emkhakheni wamadivayisi wezokwelapha (asikho isidingo esicacile kumqondisi we-MDD);
b) Umkhiqizi uzosungula futhi ngokuqhubekayo avuselele imibhalo yezobuchwepheshe futhi aqinisekise ukuthi iyatholakala lapho icelwe igunya elifanele kuzwelonke.
c) Abakhiqizi kumele baphendule ekuhlolweni okungamelwe ukuthi bahlolwe yimizimba eyazisiwe nganoma yisiphi isikhathi ukuqinisekisa ukuvuselelwa kwemibhalo yezobuchwepheshe kanye nokunakekelwa kohlelo; (Imikhiqizo yeklasi II)
d) Yemikhiqizo enobungozi obukhulu bezinkampani zokuhweba, kuzoba nzima kakhulu ukufaka isicelo se-CE.
2) Ukwanda kokuhlinzekwa kokulawulwa kokulawulwa nokubuyekezwa kwesitifiketi esiqinile.
a) ukukhulisa imithetho yokuhlukaniswa: kusuka ku-18 e-MDD kuya ku-22 ku-MDR;
b) Izinto zohlu lokuhlola izidingo eziyisisekelo ziyanda: kusuka ezintweni eziyi-13 ku-MDD kuya kwezingu-23 ku-MDR;
c) Ukwakheka kwezobuchwepheshe ze-CE kushintshile futhi kuhlukaniswe: Imibhalo yezobuchwepheshe yomkhiqizo kanye nemibhalo ye-Post-Marketing (MDD kuphela idinga imibhalo yobuchwepheshe yomkhiqizo);
d) Umbiko wokuhlola umtholampilo. I-MDR idinga izinkampani ukuhlinzeka ngohlobo lwesine lwemibiko yokuhlola imitholampilo, eqinile kunenguqulo yesithathu;
3) Ububanzi obunwetshiwe
a) I-MDD ihlose kuphela imikhiqizo ngezinhloso zokwelashwa, kanti i-MDR ifaka amadivaysi angewona ezokwelapha esikalini sohlelo lokusebenza, njengelensi yokuxhumana yemifino, imikhiqizo yobuhle, njll.;
b) kuma-MDD, amadivaysi atholakalayo ahlukaniswa njengeklasi lamadivaysi ezokwelapha futhi awadingi ukungenelela komzimba owazisiwe, ngenkathi i-MDR idinga umzimba okwazisiwe ukwenza ukuhlolwa kokuhlinzwa kwamadivayisi anokuhlinza avuselelwayo;
4) I-MDR idinga ukucaca okukhulu nokulandela umkhondo
a) wethula idivaysi eyingqayizivele yokuhlonza i-UDI ukwandisa ukulandelela komkhiqizo;
b) Imininingwane efanele yenkampani izoqoqwa kwi-database ye-European Medical Database (eudimed);
c) Sungula uhlelo lwe-Post-Market Surveillance (PMS);
d) Umzimba owazisiwe uzoqhuba ukuhlolwa okungagcinwanga.
Kuyini ukuhlolwa kwemitholampilo kwe-MDR CE?
Umkhuba Wezempilo esikhuluma ngawo uhlukaniswe ngezindlela ezimbili:
a) Ukuvivinywa kwemitholampilo kusetshenziswa kubantu ukuthola idatha ukufakazela ukuphepha komkhiqizo.
b) Imibiko yemitholampilo ifakazela ngokukhethekile ukuphepha nokusebenza kahle komkhiqizo ngokuqhathanisa komkhiqizo (kusuka ezicini ezintathu: idatha yezobuchwepheshe, amapharamitha wezobuchwepheshe, nokusebenza kwemvelo), ukuhlaziya idatha, kanye nokubuyekezwa kwezincwadi.
c) Umbiko wokuhlola umtholampilo uyingxenye yedokhumenti yezobuchwepheshe ye-CE futhi futhi uyingxenye ebalulekile (Umbiko wokuhlola umtholampilo ungumbiko obaluleke kakhulu kudokhumenti lobuchwepheshe be-CE lapho ufaka isitifiketi se-CE).
d) Okwamanje, inguqulo yesine yoMbiko Wokuhlola Wezempilo, okuyinto yombiko wokuhlola umtholampilo ohlanganiswe ngokuhambisana nomhlahlandlela wokuhlola umhlahlandlela we-Meddev 2.7.1.
Isitifiketi se-MDR esidlulayo sisho ukuthi I-JoyTech Pressure Pressure Monitor kanye I-Digital Thermometer ifinyelele kumazinga aqinile ekwakhiweni, ekukhiqizeni nasekulawulweni kwekhwalithi, futhi inganikeza amadivaysi aphephile nethembekile bezokwelapha kubasebenzisi emhlabeni jikelele.
I-JoyTech Pressure Pressure Monitor kanye ne-Thermometer yedijithali iwine indumiso engenakuqhathaniswa kusuka kubasebenzisi ngemiphumela yabo yokulinganisa enembile, ukwakheka okuhle nokusebenza okuhle. Manje, badlule isitifiketi se-MDR, ngokungangabazeki esizothuthukisa ukwethembana kwabasebenzisi nokwaneliseka emikhiqizweni yethu.
I-JoyTech Healthcare izoqhubeka nokuzibophezela ekuhlinzekeni Amadivayisi wezokwelapha asezingeni eliphakeme futhi afaka isandla empilweni yabasebenzisi emhlabeni wonke. Sikholwa ukuthi ngemizamo yethu, imikhiqizo yethu yekhwalithi izosiza empilweni yakho enempilo emakethe yomhlaba.
Uma unemibuzo noma izidingo mayelana nomqaphi wethu wegazi wegazi nemikhiqizo ye-thermometer, sicela ukhululeke ukuxhumana nathi.
