Dab tsi yog EU MDR txhais tau?
EU MDR yog European Union Medical Device Regulation 2017/745 uas tau tso tawm xyoo 2017 los ntawm European Parliament thiab Council ntawm European Union. Lub hom phiaj ntawm EU MDR cov kev tswj hwm yog ua kom muaj cov txheej txheem kev nyab xeeb thiab zoo rau cov khoom siv kho mob uas tsim tawm hauv, los yog muab rau, cov tswv cuab ntawm cov teb chaws EU.
Cov kab ke tswj hwm no yog tsim los txheeb xyuas cov cuab yeej kho mob kom zoo, ntxiv rau cov ntaub ntawv ua kom zoo thiab cov kev siv thev naus laus zis los ntawm EU cov ntaub ntawv (Eudamed). Txoj cai EU MDR yog npaj los ua cov qauv kev tswj hwm rau cov cuab yeej siv kho mob uas tuaj yeem saib xyuas kev noj qab haus huv& kev nyab xeeb thaum tseem muaj txhawb txhawb kev tsim kho.
MDD thiab MDR yog dab tsi?
European Union Medical Device Directive (MDD) tau muaj nyob rau yuav luag 25 xyoo ua ntej nws tau hloov los ntawm European Union Medical Device Regulation (MDR), muab tawm xyoo 2017. Cov lus qhia dhau los no tau tsim tsab cai EU rau cov khoom kho mob, tab sis nws tsis suav nrog hauv vitro kuaj mob.
Txawm li cas los xij, nws tau txiav txim siab tias ib qho kev hloov kho tseem ceeb ntawm cov lus qhia yog qhov tsim nyog los tsim kom muaj kev ruaj khov dua, muaj pob tshab, ruaj khov, thiab paub txog kev cai tswj hwm. Lub hom phiaj yog txhawm rau txhim kho qib tag nrho ntawm kev noj qab haus huv thiab kev nyab xeeb ntawm cov cuab yeej siv kho mob, thaum tseem txhawb txoj kev tsim kho tshiab hauv kev lag luam.
Thaum twg EU MDR luam tawm?
Thaum pawg sab laj lub Plaub Hlis 4, 2017, nyob rau European cov cuab yeej siv tshuaj kho mob tau ua lub luag haujlwm tsim cov kev cai tshiab, EU MDR txoj cai tau tshaj tawm thaum lub Tsib Hlis 5, 2017. Nws muaj peb lub sijhawm hloov mus rau cov tuam txhab kom ua raws li cov kev cai tshiab MDR EU kev cai.
Thaum twg EU MDR yuav siv?
Thaum cov tuam txhab tuaj yeem pib ua raws li cov kev cai tshiab tam sim ntawd, lub sijhawm hloov ntawm EU MDD qhia rau EU MDR cov cai kav rau plaub lub xyoos thiab xaus rau 26 Tsib Hlis 2021. Tom qab hnub no, txhua yam cuab yeej khomob tshiab yuav tsum tau tau ntawv pov thawj rau EU kev cai MDR tshiab. Cov MDD-ntawv kho mob uas twb muaj lawm tau muaj lub sijhawm hloov pauv ntxiv kom txog thaum lub Tsib Hlis 2024 txhawm rau hloov lawv cov ntaub ntawv pov thawj kom ua raws li MDR EU cov cai tshiab.
Hnub twg yuav tsum muaj tag nrho cov MDD muaj ntawv pov thawj uas tau txais ntawv pov thawj raws li MDR?
Hnub kawg rau txhua yam MDD-tau txais ntawv pov thawj yuav tsum tau ntawv pov thawj hauv MDR tshiab yog Lub Tsib Hlis 25, 2024. Yog tias cov khoom siv kho mob ua tau raws li EU MDR cov cai ua ntej hnub no, ces nws tuaj yeem tau ntawv pov thawj nyob hauv MDR, tab sis nws tsis yog yuav tsum yog nws MDD daim ntawv pov thawj tseem siv tau. Yog tias MDD daim ntawv pov thawj tag sijhawm ua ntej 25 Tsib Hlis 2024, tom qab ntawv MDR yuav tsum rov qab tsim kho dua tshiab raws li MDR.
Hnub kawg los ua daim ntawv pov thawj kawg no raws li EU MDR yog Lub Tsib Hlis 25, 2024– tom qab hnub tim no, txhua txhua cov khoom siv tso rau hauv khw yuav tsum muaj ntawv pov thawj raws li EU Txoj Cai Tswj Khoom Mob.
Yuav ua li cas EU MDR?
EU Txoj Cai Tswj Xyuas Cov Khoom Siv Kho Mob (Medical Device Regulation) tau tsim cov cim kev cim cov cim cuab yeej (UDI) uas zoo ib yam li Tebchaws Meskas Cov Khoom Siv thiab Tshuaj (FDA). Yog tias lub tuam txhab npaj siab yuav muab lossis faib cov cuab yeej siv kho mob mus rau hauv EU kev ua lag luam, daim ntawv lo rau ntawm cov khoom lag luam yuav xav ua raws li cov txheej txheem tshiab UDI no. Kev ua raws li cov kev cai MDR tshiab yog txoj cai yuav tsum muaj rau cov tuam txhab kev kho mob uas npaj siab muag cov khoom lag luam hauv Tebchaws Europe.
MDR ntawv pov thawj yog dab tsi?
MDR ntawv pov thawj ntawm cov cuab yeej siv tshuaj kho mob pom tseeb tias cov cuab yeej ua tau raws li tag nrho cov kev cai rau European Union cov cuab yeej kho mob; ntawv pov thawj yog qhia los ntawm CE Mark.
Txhawm rau kom cov cuab yeej siv kho mob tau ntawv pov thawj, koj lub tuam txhab yuav tsum siv qhov Kev Tswj Xyuas Kev Ua Haujlwm Zoo (QMS). Ntau lub tuam txhab siv ISO 13485 ua ib txoj hauv kev siv QMS no, vim tias qhov no tsuas yog QMS cov qauv ntawm EU cov npe khoom, thiab vim li ntawd nws yog qhov zoo tshaj plaws los siv QMS raws li kev cuam tshuam nrog MDR EU cov kev cai.