Ka 28 la .Mmesa 2022, Joytech e ile ea fumana tlhahiso ea pele ea EU MDR bakeng sa li-monitor tsa rona tse sa hlaseleng khatello ea mali, o ka fumana lintlha tse felletseng. Mona.
Ka 2023, li-thermometer tsa Joytech, li-thermometer tse sa amaneng le li-monitor tse ncha tsa khatello ea mali kaofela li amohetsoe ke EU MDR.
CE (MDR) ke eng?
Ha ho tluoa ho setifikeiti sa CE, motho e mong le e mong oa e tseba.Hoo e ka bang indasteri e 'ngoe le e' ngoe e na le setifikeiti se lumellanang sa CE.MDR ke khutsufatso ea European Medical Device Regulation, e leng ntlafatso ea CE (MDD) mme e beha litlhoko tse phahameng mabapi le polokeho le ts'ebetso ea lisebelisoa tsa bongaka.Re boetse re e bitsa CE (MDR).
Phapang ke efe lipakeng tsa CE (MDD) le CE (MDR)?
MDR ke taolo mme MDD ke taelo.Hobane ke ntlafatso, ho tloha ho litaelo ho ea ho melaoana, linaha tseo e leng litho tsa EU li tla sebelisa taolo e thata holim'a ts'ebetso ea setifikeiti le liphetho.
E bonts'oa haholo-holo likarolong tse latelang:
1) E matlafalitse boikarabello ba moetsi.
a) Moetsi o tlameha ho ba le bonyane ofisiri e le 'ngoe ea tsamaiso e nang le boiphihlelo lefapheng la lisebelisoa tsa bongaka (ha ho na tlhoko e hlakileng ho taelo ea MDD);
b) Moetsi o tla theha le ho tsoela pele ho ntlafatsa litokomane tsa tekheniki le ho netefatsa hore lia fumaneha ha li kopuoa ke bolaoli bo nang le bokhoni ba naha.
c) Baetsi ba tlameha ho arabela tlhahlobo e sa boleloang ke mekhatlo e tsebisitsoeng ka nako efe kapa efe ho netefatsa ntlafatso ea litokomane tsa tekheniki le tlhokomelo ea sistimi;(Lihlahisoa tsa sehlopha sa II)
d) Bakeng sa lihlahisoa tse kotsing e kholo ea lik'hamphani tsa khoebo, ho tla ba thata le ho feta ho etsa kopo ea CE.
2) Litokisetso tse eketsehileng tsa taolo le tlhahlobo e thata ea setifikeiti.
a) Melao e ekelitsoeng ea lihlopha: ho tloha ho 18 ho MDD ho ea ho 22 ho MDR;
b) Lintlha tsa lethathamo la litlhoko tsa mantlha lia eketseha: ho tloha ho lintho tse 13 ho MDD ho ea ho tse 23 ho MDR;
c) Sebopeho sa litokomane tsa tekheniki tsa CE se fetohile mme se arotsoe ka: litokomane tsa tekheniki ea sehlahisoa le litokomane tsa morao-rao tsa ho bapatsa (MDD e hloka feela litokomane tsa tekheniki ea sehlahisoa);
d) Tlaleho ea tlhahlobo ea bongaka.MDR e hloka hore lik'hamphani li fane ka tlaleho ea bone ea litlaleho tsa tlhahlobo ea meriana, e thata ho feta ea boraro;
3) Boemo bo atolositsoeng ba ts'ebeliso
a) MDD e shebana le lihlahisoa feela ka sepheo sa bongaka, athe MDR e kenyelletsa lisebelisoa tse ling tseo e seng tsa bongaka molemong oa ts'ebeliso, joalo ka lilense tsa meroho, lihlahisoa tsa botle, joalo-joalo;
b) Ho MDD, lisebelisoa tse ka sebelisoang hape li khetholloa e le sehlopha sa lisebelisoa tsa bongaka 'me ha li hloke ho kenella ha sehlopha se tsebisitsoeng, ha MDR e hloka sehlopha se tsebisitsoeng ho etsa tlhahlobo ea ho lumellana le lisebelisoa tsa ho buoa tse ka sebelisoang hape;
4) MDR e hloka pepeneneng le ho lateloa ho hoholo
a) E hlahisitse UDI e khethollang sesebelisoa ho eketsa ts'ebetso ea sehlahisoa;
b) Boitsebiso bo loketseng ba k'hamphani bo tla bokelloa ho Database ea European Medical Device Database (EUDAMED);
c) Theha mokhoa oa ho beha leihlo ka mor'a 'maraka (PMS);
d) Sehlopha se tsebisitsoeng se tla etsa litlhahlobo tse sa boleloang.
Tlhahlobo ea bongaka ea MDR CE ke efe?
Mekhoa ea kliniki eo re buang ka eona hangata e arotsoe ka mefuta e 'meli:
a) Liteko tsa bongaka li sebelisoa ho batho ho fumana lintlha ho paka polokeho ea sehlahisoa.
b) Litlaleho tsa bongaka li paka haholo polokeho le katleho ea sehlahisoa ka ho bapisa sehlahisoa (ho tsoa likarolong tse tharo: lintlha tsa bongaka, litekanyetso tsa tekheniki, le ts'ebetso ea baeloji), tlhahlobo ea lintlha, le tlhahlobo ea lingoliloeng.
c) Tlaleho ea tlhahlobo ea bongaka ke karolo ea tokomane ea tekheniki ea CE hape ke karolo ea bohlokoa (tlaleho ea tlhahlobo ea bongaka ke tlaleho ea bohlokoa tokomaneng ea tekheniki ea CE ha o etsa kopo ea setifikeiti sa CE).
d) Hajoale, phetolelo ea bone ea tlaleho ea tlhahlobo ea bongaka e kentsoe tšebetsong, e leng tlaleho ea tlhahlobo ea bongaka e hlophisitsoeng ho latela tataiso ea tlhahlobo ea bongaka MedDev 2.7.1.
Ho fetisa setifikeiti sa MDR ho bolela hore Joytech khatello ea mali le ho thermometer ea dijithale e fihletse litekanyetso tse thata tsa moralo, tlhahiso le taolo ea boleng, 'me e ka fana ka lisebelisoa tsa bongaka tse sireletsehileng le tse tšepahalang ho basebelisi ho pota lefatše.
Sehlahlobi sa khatello ea mali sa Joytech le thermometer ea dijithale li hapile thoriso e le 'ngoe ho tsoa ho basebelisi ka liphetho tsa bona tse nepahetseng tsa litekanyo, moralo o bonolo oa basebelisi le ts'ebetso e ntle haholo.Hona joale, ba fetisitse setifikeiti sa MDR, seo ntle le pelaelo se tla matlafatsa tšepo le khotsofalo ea basebelisi lihlahisoa tsa rona.
Joytech Healthcare e tla tsoelapele ho ikemisetsa ho fana ka lisebelisoa tsa bongaka tsa boleng bo holimo le ho kenya letsoho ho bophelo bo botle ba basebelisi lefatšeng ka bophara.Re lumela hore ka boiteko ba rona, lihlahisoa tsa rona tsa boleng bo botle li tla thusa bophelong ba hau bo botle 'marakeng oa lefatše.
Haeba u na le lipotso kapa litlhoko mabapi le lisebelisoa tsa rona tsa khatello ea mali le lihlahisoa tsa thermometer, ka kopo ikutloe u lokolohile ho ikopanya le rona.
