28 Ngomhlaka .Ngo-Ephreli 2022, i-Joytech yathola ukukhishwa kokuqala kwe-EU MDR yamaqapha wethu wegazi angavaleli, ungathola imininingwane lapha.
Ngo-2023, ama-thermometer okuxhumana akwa-Joytech, ama-thermometer angathinteki kanye neziqaphi ezintsha zomfutho wegazi konke kugunyazwe yi-EU MDR.
Iyini i-CE (MDR)?
Uma kukhulunywa ngezitifiketi ze-CE, wonke umuntu uyayazi.Cishe yonke imboni inesitifiketi se-CE esihambisanayo.I-MDR isifinyezo se-European Medical Device Regulation, okuwukubuyekezwa kwe-CE (MDD) futhi ibeka izidingo eziphakeme ekuphepheni nasekusebenzeni kwemishini yezokwelapha.Siphinde siyibize nge-CE (MDR).
Uyini umehluko phakathi kwe-CE (MDD) ne-CE (MDR)?
I-MDR ingumthetho futhi i-MDD iyisiqondiso.Ngenxa yokuthi kuwukuthuthuka, kusukela eziqondisweni kuya eziqondisweni, amazwe angamalungu e-EU azosebenzisa ukulawula okuqinile phezu kwenqubo yokunikezwa kwezitifiketi kanye nemiphumela.
Ibonakala kakhulu kulezi zici ezilandelayo:
1) Kuqiniswe izibopho zomenzi.
a) Umkhiqizi kufanele okungenani abe nesikhulu esisodwa sokuthobela esinolwazi emkhakheni wemishini yezokwelapha (ayikho imfuneko ecacile kumyalelo we-MDD);
b) Umkhiqizi kufanele asungule futhi aqhubeke evuselela imibhalo yezobuchwepheshe futhi aqinisekise ukuthi ayatholakala uma ecelwa isiphathimandla sikazwelonke esinekhono.
c) Abakhiqizi kumele baphendule ekuhlolweni okungamenyezelwa yizindikimba ezazisiwe nganoma yisiphi isikhathi ukuze kuqinisekiswe ukubuyekezwa kwemibhalo yezobuchwepheshe kanye nokugcinwa kokugcinwa kohlelo;(Imikhiqizo ye-Class II)
d) Ngemikhiqizo esengozini enkulu yezinkampani ezihwebayo, kuzoba nzima kakhulu ukufaka isicelo se-CE.
2) Ukwenyuswa kwemibandela yokulawula kanye nokubuyekezwa kwesitifiketi esiqinile.
a) Ukwenyuka kwemithetho yokuhlukanisa: kusuka ku-18 ku-MDD kuya ku-22 ku-MDR;
b) Izinto zohlu lokuhlola izidingo eziyisisekelo ziyandiswa: zisuka ezintweni eziyi-13 ku-MDD ziye kwezingama-23 ku-MDR;
c) Isakhiwo semibhalo yezobuchwepheshe ye-CE sishintshile futhi sihlukaniswe: imibhalo yezobuchwepheshe bomkhiqizo kanye nemibhalo yangemva kokumakethwa (i-MDD idinga kuphela imibhalo yezobuchwepheshe yomkhiqizo);
d) Umbiko wokuhlolwa komtholampilo.I-MDR idinga izinkampani ukuthi zinikeze inguqulo yesine yemibiko yokuhlolwa komtholampilo, eqinile kunenguqulo yesithathu;
3) Ububanzi obunwetshiwe besicelo
a) I-MDD iqondise kuphela imikhiqizo enezinjongo zokwelapha, kuyilapho i-MDR ihlanganisa nezinye izinto ezingezona ezokwelashwa kububanzi bokusebenza, njengamalensi okuxhumana emifino, imikhiqizo yobuhle, njll.;
b) Ku-MDD, izinto ezisebenziseka kabusha zihlukaniswa njengezigaba zemishini yezokwelapha futhi azidingi ukungenelela kwendikimba eyazisiwe, kuyilapho i-MDR idinga indikimba eyazisiwe ukuthi yenze ukuhlola ukuhambisana kwemishini yokuhlinza engasetshenziswa kabusha;
4) I-MDR idinga ukucaca okukhulu nokulandeleka
a) Sethule isihlonzi sedivayisi esiyingqayizivele i-UDI ukuze kwandiswe ukulandeleka komkhiqizo;
b) Ulwazi olufanele lwenkampani luzoqoqwa ku-European Medical Device Database (EUDAMED);
c) Ukusungula uhlelo lokugada ngemuva kokudayisa (i-PMS);
d) Umgwamanda owazisiwe uzokwenza ukuhlolwa okungamenyezelwanga.
Kuyini ukuhlolwa komtholampilo kwe-MDR CE?
Umkhuba womtholampilo esikhuluma ngawo uhlukaniswe waba izinhlobo ezimbili:
a) Izivivinyo zemitholampilo zisetshenziswa kubantu ukuze bathole idatha ukufakazela ukuphepha komkhiqizo.
b) Imibiko yomtholampilo ikakhulukazi ifakazela ukuphepha nokusebenza ngempumelelo komkhiqizo ngokuqhathanisa umkhiqizo (kusukela ezicini ezintathu: idatha yomtholampilo, imingcele yobuchwepheshe, nokusebenza kwebhayoloji), ukuhlaziya idatha, nokubuyekezwa kwezincwadi.
c) Umbiko wokuhlolwa komtholampilo uyingxenye yombhalo wezobuchwepheshe we-CE futhi uyingxenye ebalulekile (umbiko wokuhlolwa komtholampilo uwumbiko obalulekile emqulwini wezobuchwepheshe we-CE lapho ufaka isicelo sesitifiketi se-CE).
d) Njengamanje, inguqulo yesine yombiko wokuhlolwa komtholampilo iyasebenza, okuwumbiko wokuhlolwa komtholampilo ohlanganiswe ngokuvumelana nesiqondiso sokuhlolwa komtholampilo i-MedDev 2.7.1.
Ukuphasisa isitifiketi se-MDR kusho lokho Joytech blood pressure monitor kanye I-thermometer yedijithali ifinyelele izindinganiso eziqinile ekuklameni, ekukhiqizeni nasekulawuleni ikhwalithi, futhi ingahlinzeka ngamadivaysi ezokwelapha aphephile futhi anokwethenjelwa kakhudlwana kubasebenzisi emhlabeni jikelele.
I-Joytech blood pressure monitor kanye ne-digital thermometer zizuze ukunconywa ngazwi linye kubasebenzisi ngemiphumela yabo yokulinganisa enembile, idizayini esebenziseka kalula kanye nokusebenza okuhle kakhulu.Manje, sebesitholile isitifiketi se-MDR, ngokungangabazeki esizothuthukisa ukwethemba nokwaneliseka kwabasebenzisi emikhiqizweni yethu.
IJoytech Healthcare izoqhubeka nokuzinikela ekuhlinzekeni imishini yezokwelapha yekhwalithi ephezulu futhi enikela empilweni yabasebenzisi emhlabeni jikelele.Sikholelwa ukuthi ngemizamo yethu, imikhiqizo yethu yekhwalithi izosiza empilweni yakho enempilo emakethe yomhlaba.
Uma unemibuzo noma izidingo mayelana ne-blood pressure monitor kanye nemikhiqizo ye-thermometer, sicela ukhululeke ukusithinta.
