28 Hnub .Lub Plaub Hlis 2022, Joytech tau txais thawj qhov kev tshaj tawm ntawm EU MDR rau peb cov ntsuas ntshav siab uas tsis cuam tshuam, koj tuaj yeem paub cov ntsiab lus ntawm no.
Xyoo 2023, Joytech tiv tauj cov ntsuas kub, cov ntsuas kub tsis sib cuag thiab ntsuas ntshav siab tshiab yog tag nrho EU MDR pom zoo.
CE (MDR) yog dab tsi?
Thaum nws los txog rau daim ntawv pov thawj CE, txhua tus paub txog nws.Yuav luag txhua qhov kev lag luam muaj daim ntawv pov thawj CE.MDR yog lub npe luv ntawm European Medical Device Regulation, uas yog qhov hloov tshiab ntawm CE (MDD) thiab tsim kom muaj kev ruaj ntseg thiab kev ua haujlwm ntawm cov cuab yeej kho mob.Peb kuj hu nws CE (MDR).
Dab tsi yog qhov txawv ntawm CE (MDD) thiab CE (MDR)?
MDR yog txoj cai thiab MDD yog cov lus qhia.Vim tias nws yog ib qho kev hloov kho tshiab, los ntawm cov lus qhia mus rau cov kev cai, EU cov tswvcuab yuav siv zog tswj cov txheej txheem ntawv pov thawj thiab cov txiaj ntsig.
Feem ntau yog reflected nyob rau hauv cov nram qab no yam:
1) Txhim kho cov chaw tsim khoom lub luag haujlwm.
a) Cov chaw tsim khoom yuav tsum muaj tsawg kawg yog ib tus tub ceev xwm ua raws li cov kws tshaj lij hauv cov khoom siv kho mob (tsis muaj qhov qhia meej meej hauv MDD cov lus qhia);
b) Cov chaw tsim khoom yuav tsum tsim thiab tsis tu ncua hloov kho cov ntaub ntawv kev txawj ntse thiab xyuas kom meej tias nws muaj nyob rau thaum thov los ntawm lub tebchaws muaj peev xwm.
c) Cov neeg tsim khoom yuav tsum teb rau qhov kev tshuaj xyuas tsis tau tshaj tawm los ntawm lub cev tau ceeb toom txhua lub sijhawm los xyuas kom meej qhov hloov tshiab ntawm cov ntaub ntawv kev tshaj lij thiab kev saib xyuas lub cev;(Class II khoom)
d) Rau cov khoom pheej hmoo siab ntawm cov tuam txhab lag luam, nws yuav nyuaj dua rau kev thov rau CE.
2) Txhim kho cov kev cai tswj hwm thiab kev tshuaj xyuas cov ntawv pov thawj nruj dua.
a) Cov kev cai muab faib ntxiv: los ntawm 18 hauv MDD mus rau 22 hauv MDR;
b) Cov ntaub ntawv txheeb xyuas cov ntsiab lus tseem ceeb tau nce: los ntawm 13 yam khoom hauv MDD mus rau 23 yam khoom hauv MDR;
c) Cov qauv ntawm cov ntaub ntawv CE tau hloov pauv thiab muab faib ua: cov ntaub ntawv kev lag luam khoom thiab cov ntaub ntawv tom qab kev lag luam (MDD tsuas yog xav tau cov ntaub ntawv tsim khoom);
d) Daim ntawv ntsuam xyuas kev soj ntsuam.MDR xav kom cov tuam txhab muab cov ntawv thib plaub ntawm cov ntaub ntawv soj ntsuam kev soj ntsuam, uas yog nruj dua li qhov thib peb;
3) nthuav dav ntawm daim ntawv thov
a) MDD tsuas yog lub hom phiaj cov khoom lag luam nrog lub hom phiaj kho mob, thaum MDR suav nrog qee cov khoom siv tsis yog tshuaj kho mob rau hauv daim ntawv thov, xws li zaub tiv thaiv lo ntsiab muag, khoom zoo nkauj, thiab lwm yam;
b) Hauv MDD, cov khoom siv rov siv tau raug cais raws li chav kawm ntawm cov cuab yeej siv kho mob thiab tsis tas yuav muaj kev cuam tshuam ntawm lub cev tau ceeb toom, thaum MDR xav kom lub cev tau ceeb toom los ua qhov kev ntsuas kev sib raug zoo ntawm cov khoom siv phais uas siv tau;
4) MDR xav kom muaj qhov pom tseeb dua thiab traceability
a) Qhia cov cim ntaus cim tshwj xeeb UDI txhawm rau txhawm rau txhim kho cov khoom lag luam;
b) Cov ntaub ntawv ntsig txog ntawm lub tuam txhab yuav raug sau rau hauv European Medical Device Database (EUDAMED);
c) Tsim kom muaj kev soj ntsuam tom qab kev lag luam (PMS) system;
d) Lub koom haum ceeb toom yuav ua kev tshuaj xyuas tsis tau tshaj tawm.
Qhov kev ntsuam xyuas ntawm MDR CE yog dab tsi?
Kev kho mob peb tab tom tham txog feem ntau muab faib ua ob hom:
a) Kev sim tshuaj yog siv rau tib neeg kom tau txais cov ntaub ntawv los ua pov thawj kev nyab xeeb ntawm cov khoom.
b) Cov ntaub ntawv soj ntsuam feem ntau ua pov thawj kev nyab xeeb thiab kev ua tau zoo ntawm cov khoom los ntawm kev sib piv cov khoom lag luam (los ntawm peb yam: cov ntaub ntawv kho mob, cov khoom siv tsis zoo, thiab kev ua haujlwm lom neeg), cov ntaub ntawv txheeb xyuas, thiab cov ntaub ntawv tshuaj xyuas.
c) Daim ntawv ntsuam xyuas kev soj ntsuam yog ib feem ntawm CE cov ntaub ntawv kev kawm thiab tseem yog ib feem tseem ceeb (cov ntaub ntawv ntsuam xyuas kev soj ntsuam yog ib qho tseem ceeb ntawm cov ntaub ntawv CE thaum thov rau CE daim ntawv pov thawj).
d) Tam sim no, qhov thib plaub ntawm daim ntawv ntsuam xyuas kev soj ntsuam tau raug coj los siv, uas yog daim ntawv ntsuam xyuas kev soj ntsuam tau muab tso ua ke raws li kev soj ntsuam kev soj ntsuam MedDev 2.7.1.
Dhau MDR daim ntawv pov thawj txhais tau tias Joytech ntshav siab saib xyuas thiab cov ntsuas kub digital tau mus txog cov qauv nruj hauv kev tsim, tsim khoom thiab tswj kom zoo, thiab tuaj yeem muab cov cuab yeej kho mob muaj kev nyab xeeb thiab txhim khu kev qha rau cov neeg siv thoob ntiaj teb.
Joytech ntshav ntsuas ntshav ntsuas thiab ntsuas tus ntsuas kub digital tau txais kev qhuas zoo los ntawm cov neeg siv rau lawv qhov kev ntsuas qhov tseeb, tus neeg siv tus qauv tsim thiab kev ua haujlwm zoo heev.Tam sim no, lawv tau dhau los ntawm MDR daim ntawv pov thawj, uas yuav tsis muaj kev poob siab ntxiv txhim kho cov neeg siv kev ntseeg siab thiab txaus siab rau peb cov khoom.
Joytech Healthcare tseem yuav cog lus rau kev muab cov cuab yeej kho mob zoo thiab pab txhawb kev noj qab haus huv ntawm cov neeg siv thoob ntiaj teb.Peb ntseeg tias los ntawm peb cov kev siv zog, peb cov khoom zoo yuav pab tau koj lub neej noj qab nyob zoo hauv kev lag luam thoob ntiaj teb.
Yog tias koj muaj lus nug lossis xav tau ntawm peb cov khoom ntsuas ntshav siab thiab ntsuas kub, thov koj xav tiv tauj peb.
