CE-certified orthodontic khoom ua si lub luag haujlwm tseem ceeb hauv kev kho hniav niaj hnub los ntawm kev ua kom muaj kev nyab xeeb thiab zoo. Cov khoom no ua tau raws li European Union cov qauv nruj, lav lawv txoj kev ntseeg siab rau cov neeg mob thiab cov kws kho mob. EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR) tau qhia cov kev cai nruj heev los txhim kho cov neeg mob kev nyab xeeb. Piv txwv li:
- Cov cuab yeej kho hniav yuav tsum tam sim notraceable rau lawv cov txheej txheem sterilization.
- Cov kws kho hniav siv CAD/CAM thev naus laus zis ntsib kev ua raws cai ntxiv, suav nrog kev tswj hwm kev pheej hmoo.
Kev ua raws li cov qauv no tiv thaiv cov neeg mob thiab ua kom cov chaw kho hniav ua tau raws li kev lav phib xaub, txhawb kev ntseeg siab thiab kev tshaj lij hauv kev ua haujlwm.
Ntsiab Cai
- Daim ntawv pov thawj CE qhia tau hais tias cov khoom siv orthodontic muaj kev nyab xeeb thiab zoo.
- Cov chaw kho hniav yuav tsum kuaj xyuas cov ntawv thiab nug cov ntaub ntawv kom paub meej CE daim ntawv pov thawj.
- Kev kuaj xyuas tsis tu ncua pab cov tsev kho mob pom cov teeb meem thiab ua raws EU MDR cov cai kom cov neeg mob muaj kev nyab xeeb.
- Kev yuav los ntawm cov neeg muag khoom ntseeg siab txo qis kev pheej hmoo thiab txhim kho kev saib xyuas neeg mob.
- Kev qhia cov neeg ua haujlwm txog EU MDR cov cai pab txhua tus paub yuav ua li cas kom cov khoom muaj kev nyab xeeb thiab zoo.
Dab tsi yog CE-Certified Orthodontic Products?
Txhais thiab Lub Hom Phiaj ntawm CE Certification
Daim ntawv pov thawj CE yog lub cim ntawm kev ua tau zoo thiab kev nyab xeeb lees paub thoob plaws European Union. Nws qhia tau hais tias ib yam khoom ua raws li EU cov cai, ua kom nws ua tau raws li kev noj qab haus huv, kev nyab xeeb, thiab kev tiv thaiv ib puag ncig. Rau cov khoom siv orthodontic, daim ntawv pov thawj no tau lees tias lawv muaj kev nyab xeeb rau cov neeg mob thiab siv tau zoo hauv lawv txoj kev npaj. Cov chaw kho hniav cia siab rau CE-certified orthodontic khoom kom muaj kev saib xyuas zoo thiab tsim kev ntseeg siab nrog lawv cov neeg mob.
Lub hom phiaj ntawm daim ntawv pov thawj CE txuas ntxiv dhau kev ua raws. Nws kuj txhawb kev sib xws hauv cov khoom lag luam zoo thoob plaws EU kev lag luam. Qhov no ua kom ntseeg tau tias cov khoom siv orthodontic, xws li brackets thiab cov xov hlau, ua tau zoo txawm tias lawv tsim los yog siv qhov twg.
CE Certification txheej txheem rau Orthodontic khoom
Cov txheej txheem ntawv pov thawj CE rau cov khoom siv orthodontic suav nrog ntau cov kauj ruam tseem ceeb. Cov neeg tsim khoom yuav tsum ua ntejnkag siab txog kev ua lag luam tshwj xeeb, suav nrog kev xav tau CE kos npe hauv EU. Tom qab ntawd lawv yuav tsum xyuas kom meej tias lawv cov khoom ua tau raws li qhov tseem ceeb ntawm kev nyab xeeb thiab kev ua haujlwm tau teev tseg hauv EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR). Kev koom tes nrog cov koom haum kuaj thib peb uas tau lees paub yog qhov tseem ceeb rau kev soj ntsuam nruj ntawm cov khoom ua raws li cov khoom lag luam thiab kev ua tau zoo.
Kev hloov kho tshiab ntawm kev tswj hwm kev hloov pauv yog lwm qhov tseem ceeb ntawm cov txheej txheem. Cov ntawv tshaj tawm kev lag luam thiab cov kws paub txog kev cai lij choj muab kev nkag siab zoo rau cov sijhawm ua raws sijhawm thiab cov qauv hloov pauv. Thaum ib qho khoom lag luam dhau tag nrho cov kev ntsuam xyuas, nws tau txais CE cim, qhia txog nws qhov kev npaj rau EU ua lag luam.
Piv txwv ntawm CE-Certified Orthodontic Products
CE-certified orthodontic products encompass ntau yam ntawm cov cuab yeej thiab cov cuab yeej siv hauv cov chaw kho hniav. Piv txwv xws li orthodontic brackets, archwires, thiab aligners. Cov khoom no tau txais kev soj ntsuam nruj kom ntseeg tau tias lawv ua tau raws li cov qauv siab tshaj plaws ntawm kev nyab xeeb thiab kev ua haujlwm. Piv txwv li, orthodontic brackets tsim los ntawm cov tuam txhab xws li Denrotary Medical yog tsim los siv cov cuab yeej siv siab heev thiab ua raws li kev tswj hwm nruj. Qhov no ua kom ntseeg tau tias cov kws kho hniav tuaj yeem tso siab rau cov khoom no kom xa cov kev kho mob zoo thiab nyab xeeb rau lawv cov neeg mob.
Nkag siab txog EU MDR Standards
Cov Lus Qhia Tseem Ceeb ntawm EU MDR rau Orthodontic Products
EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR), lub npe hu uaEU 2017/745, tsim kom muaj ib qho kev qhia dav dav rau kev tswj cov khoom siv kho mob, suav nrog cov khoom siv orthodontic. Txoj cai no tau dhau los ua qhov yuav tsum tau ua nyob thoob plaws txhua lub tebchaws EU thaum lub Tsib Hlis 2021. Nws lub hom phiaj los txhim kho kev nyab xeeb, txhawb kev tsim kho tshiab, thiab ua kom zoo ib yam.
Cov ntsiab lus tseem ceeb suav nrog:
- Tsis Muaj Txiv Neej Txoj Cai: Cov khoom siv tau pom zoo raws li Tsab Cai Kev Kho Mob yav dhau los (MDD) yuav tsum tau txais kev soj ntsuam kev ua raws li kev cai tshiab kom ua tau raws li MDR cov qauv.
- Unique Device Identifier (UDI): Txhua yam khoom siv orthodontic yuav tsum suav nrog UDI txhawm rau txhim kho traceability.
- Kev tswj kom tsis muaj menyuam: Cov cuab yeej kho hniav yuav tsum ua kom pom tseeb txog lawv cov txheej txheem kom tsis muaj menyuam.
Cov kev cai no xyuas kom meej tias cov khoom siv orthodontic ua tau raws li cov qauv kev nyab xeeb thiab kev ua tau zoo, tiv thaiv cov neeg mob thiab cov kws kho mob ib yam nkaus.
Yuav ua li cas EU MDR kom muaj kev nyab xeeb thiab kev ua tau zoo
EU MDR txhim kho kev nyab xeeb thiab kev ua tau zoo los ntawm kev ntsuas kev tswj hwm. Cov neeg tsim khoom yuav tsum muab cov ntaub ntawv pov thawj kho mob los qhia txog kev nyab xeeb thiab kev ua haujlwm ntawm lawv cov khoom. Qhov no suav nrog sau tag nrho lub neej voj voog ntawm ib lub cuab yeej.
Txoj cai tswjfwm tseem ua haujlwm rau aQuality Management System (QMS)thiab Post-Market Surveillance (PMS) system. Cov kab ke no saib xyuas cov khoom ua tau zoo thiab daws cov kev pheej hmoo. Piv txwv li, cov khoom siv orthodontic yuav tsum ua raws li ISO 14971: 2019 cov qauv rau kev tswj hwm kev pheej hmoo. Los ntawm kev xav tau cov kev ntsuas no, EU MDR txo qis qhov tshwm sim ntawm cov xwm txheej tsis zoo, xws li cov pom hauv cov cuab yeej kho mob yav dhau los.
Kev hloov tshiab tsis ntev los no hauv EU MDR Impacting Dental Clinics
Ob peb qhov hloov tshiab hauv EU MDR ncaj qha cuam tshuam rau cov chaw kho hniav. Kev hloov pauv ntawm MDD mus rau MDR, pib txij lub Tsib Hlis 2021, xav kom txhua yam khoom siv tau pom zoo los ntawm lub Tsib Hlis 2024. Qhov no ua kom muaj kev ua raws li cov qauv tshiab.
Kev taw qhia ntawm UDI system txhim kho cov khoom traceability, tshwj xeeb tshaj yog rau Class III implantable devices. Tsis tas li ntawd, cov kws kho hniav uas siv CAD/CAM thev naus laus zis tam sim no tau muab faib ua cov chaw tsim khoom. Lawv yuav tsum siv cov txheej txheem tswj xyuas kom zoo thiab ua raws li MDR cov luag num.
EUDAMED database sawv cev rau lwm qhov hloov tshiab tseem ceeb. Lub platform no sau thiab ua cov ntaub ntawv hais txog cov cuab yeej kho mob, txhim kho pob tshab thiab cov ntaub ntawv ntws. Cov kev hloov pauv no qhia txog qhov tseem ceeb ntawm kev ua raws cai rau cov chaw kho hniav siv CE-Certified Orthodontic Products.
Vim li cas Kev Ua Raws Li Qhov Tseem Ceeb rau Cov Tsev Kho Hniav
Kev pheej hmoo ntawm kev tsis ua raws li EU MDR
Kev tsis ua raws li EU MDR cov qauv ua rau muaj kev pheej hmoo loj rau cov chaw kho hniav. Kev ua txhaum cai yuav ua rau muaj kev raug cai loj heev, suav nrog kev nplua, kev nplua, lossis txawm tias raug ncua kev ua haujlwm. Cov chaw kho mob kuj tseem yuav ntsib kev puas tsuaj rau lub koob npe nrov, uas tuaj yeem cuam tshuam cov neeg mob kev ntseeg siab thiab cuam tshuam rau kev vam meej mus ntev. Tsis tas li ntawd, kev siv cov khoom siv orthodontic uas tsis ua raws cai yuav ua rau muaj qhov tshwm sim tsis zoo, xws li cov khoom siv tsis ua haujlwm lossis kev raug mob ntawm tus neeg mob, uas tuaj yeem ua rau muaj kev sib foob.
Kev ua tsis tau raws li EU MDR cov cai tuaj yeem cuam tshuam kev ua haujlwm hauv tsev kho mob. Piv txwv li, qhov tsis muaj Unique Device Identifier (UDI) ntawm cov khoom siv orthodontic tuaj yeem cuam tshuam kev taug qab, cuam tshuam kev tswj cov khoom muag thiab kev saib xyuas neeg mob. Cov chaw kho mob uas tsis quav ntsej txog kev ua raws li Kev Tswj Xyuas Zoo (QMS) lossis Kev Tshawb Fawb Tom Qab Kev Lag Luam (PMS) yuav tawm tsam los daws cov kev txhawj xeeb txog kev nyab xeeb kom zoo, nthuav tawm lawv tus kheej mus rau kev soj ntsuam xyuas.
Cov txiaj ntsig ntawm kev siv CE-Certified Orthodontic Products
Siv CE-Certified Orthodontic Products muaj ntau yam zoo rau cov chaw kho hniav. Cov khoom no ua tau raws li cov qauv kev nyab xeeb thiab kev ua tau zoo, ua kom ntseeg tau tias muaj kev kho mob zoo. Cov neeg mob tau txais txiaj ntsig los ntawm cov txiaj ntsig tau zoo, thaum cov chaw kho mob tau txais lub koob npe nrov rau kev saib xyuas zoo. Daim ntawv pov thawj CE tseem ua kom yooj yim ua raws li EU MDR cov cai, txo cov kev tswj hwm lub nra ntawm cov chaw kho mob.
Cov chaw kho mob uas saib xyuas cov khoom muaj ntawv pov thawj CE tuaj yeem txhim kho lawv cov haujlwm. Piv txwv li, traceability ntawm cov khoom no txhim khu kev tswj cov khoom muag thiab txhawb kom tsis muaj menyuam. Qhov no ua kom tag nrho cov cuab yeej ua tau raws li cov qauv kev nyiam huv, txo qis kev pheej hmoo ntawm kev kis kab mob. Tsis tas li ntawd, cov khoom lag luam tau ntawv pov thawj CE feem ntau tuaj nrog cov ntaub ntawv dav dav, ua kom yooj yim rau cov chaw kho mob kom tswj tau raws li kev cai.
Txoj cai lij choj thiab kev ncaj ncees lub luag haujlwm ntawm cov chaw kho hniav kho hniav
Cov chaw kho hniav muaj ob txoj cai lij choj thiab kev coj ncaj ncees kom ua raws li EU MDR cov qauv. Raws li txoj cai, cov chaw kho mob yuav tsum xyuas kom meej tias txhua yam khoom siv kho mob, suav nrog cov khoom siv orthodontic, ua tau raws li kev cai tswj hwm. Qhov no suav nrogsiv kev tswj hwm sab hauv, ua cov kev tshuaj xyuas tsis tu ncua, thiab tswj cov ntaub ntawv thev naus laus zis. Cov tsev kho mob tseem yuav tsum xaiv Tus Neeg Ua Haujlwm Saib Xyuas Kev Ua Raws Cai (PRRC) los saib xyuas kev ua raws li cov qauv no.
Kev ncaj ncees, cov tsev kho mob yuav tsum ua qhov tseem ceeb rau tus neeg mob kev nyab xeeb thiab kev ceev ntiag tug. Kev tuav tus neeg mob tus kheej ntiag tug, tshwj xeeb nrog cov ntaub ntawv kho mob hauv hluav taws xob, yog qhov tseem ceeb. Cov chaw kho mob yuav tsum tau txais kev tso cai pom zoo rau txhua qhov kev kho mob, siv cov lus meej thiab nkag siab. Los ntawm kev txhawb nqa kev coj noj coj ua ntawm kev ncaj ncees thiab kev pom tseeb, cov tsev kho mob tuaj yeem tsim kev ntseeg siab nrog lawv cov neeg mob thiab pab txhawb kev txhim kho tag nrho ntawm kev kho hniav.
Ua kom muaj kev ua raws li koj qhov chaw kho hniav kho hniav
Cov kauj ruam los txheeb xyuas CE Certification ntawm cov khoom
Txheeb xyuas qhovDaim ntawv pov thawj CEntawm cov khoom orthodontic yog qhov tseem ceeb rau kev ua raws li EU MDR cov qauv. Cov chaw kho hniav yuav tsum pib los ntawm kev tshuaj xyuas cov ntawv sau cov khoom. Lub cim CE yuav tsum pom meej meej, nrog rau tus lej cim ntawm lub cev ceeb toom uas ntsuas cov khoom. Cov chaw kho mob tseem yuav tsum tau thov Daim Ntawv Tshaj Tawm Txog Kev Ua Raws Cai los ntawm cov chaw tsim khoom. Cov ntaub ntawv no lees paub tias cov khoom ua tau raws li tag nrho cov kev cai tsim nyog.
Kev tshuaj xyuas cov ntaub ntawv thev naus laus zis yog lwm kauj ruam tseem ceeb. Txhua yam khoom yuav tsum muaj Daim Ntawv Qhia Kev Ntsuam Xyuas Kev Ntsuam Xyuas (CER) thiab txhawb nqa cov pov thawj ntawm kev nyab xeeb thiab kev ua haujlwm. Cov chaw kho mob tseem tuaj yeem sab laj nrog EUDAMED cov ntaub ntawv txhawm rau txheeb xyuas cov khoom lag luam kev tso npe thiab ua raws li txoj cai. Kev hloov kho cov kev kuaj xyuas no tsis tu ncua kom ntseeg tau tias txhua yam khoom siv kho hniav siv hauv tsev kho mob tseem ua raws li cov cai tam sim no.
Xaiv Reputable Suppliers rau Orthodontic Products
Xaiv cov khoom lag luam muaj npe nrov yog qhov tseem ceeb rau kev tswj hwm cov txheej txheem siab hauv kev kho hniav. Cov chaw kho mob yuav tsum tau ua qhov tseem ceeb rau cov neeg muag khoom uas ua raws li kev cai lij choj kev lag luam, xws liCE kos npe hauv EU lossis FDA pom zoo hauv AsmeskasCov koom haum kuaj thib peb ua lub luag haujlwm tseem ceeb hauv kev txheeb xyuas qhov zoo thiab ua raws li cov khoom lag luam. Cov chaw kho mob yuav tsum nug txog cov ntawv pov thawj no thaum lub sijhawm xaiv tus neeg muag khoom.
Cov ntsuas kev ua tau zoo tseem ceeb (KPIs) tuaj yeem pab ntsuas tus neeg muag khoom qhov kev ntseeg tau. Metrics zoo li cov khoom lag luam, lub sijhawm tsim khoom lag luam, thiab lub sijhawm hloov pauv muab kev nkag siab rau lawv cov kev ua tau zoo thiab hloov tau yooj yim. Teem kom meej cov qauv zoo, xws li Six Sigma qhov tsis xws luag lossis Qib Zoo Txais (AQL), ua kom cov khoom zoo sib xws. Kev koom tes nrog cov neeg muag khoom uas ua tau raws li cov qauv no txo qis kev pheej hmoo ntawm kev ua raws cai thiab txhim kho cov neeg mob kev nyab xeeb.
Kev cob qhia cov neeg ua haujlwm ntawm EU MDR Kev Ua Raws Cai
Kev cob qhia cov neeg ua haujlwm ntawm EU MDR kev ua raws cai yog txoj hauv kev zoo los xyuas kom ua raws li cov cai. Cov tsev kho mob yuav tsum npaj cov kev cob qhia thiab kev cob qhia los qhia cov neeg ua haujlwm txog MDR qhov hloov tshiab tshiab. Cov ncauj lus yuav tsum suav nrog qhov tseem ceeb ntawm daim ntawv pov thawj CE, lub luag haujlwm ntawm Cov Khoom Siv Cim Cim Cim (UDI), thiab cov kev cai rau kev tswj xyuas cov ntaub ntawv.
Cov kev cob qhia ua haujlwm tseem tuaj yeem txhim kho cov neeg ua haujlwm nkag siab txog kev ua raws li cov txheej txheem. Piv txwv li, cov neeg ua haujlwm tuaj yeem kawm paub txheeb xyuas daim ntawv pov thawj CE, tswj kev ua kom tsis muaj menyuam, thiab siv cov kev tswj hwm kev pheej hmoo. Kev cob qhia tsis tu ncua tsis tsuas yog txhim kho cov neeg ua haujlwm muaj peev xwm tab sis tseem txhawb nqa kev coj noj coj ua ntawm kev ua raws cai hauv tsev kho mob.
Ua raws li Kev Tshawb Fawb Kev Ua Raws Cai thiab Cov Ntaub Ntawv
Kev soj ntsuam kev ua raws li niaj zaus ua lub luag haujlwm tseem ceeb hauv kev ua kom ntseeg tau tias cov chaw kho hniav ua raws li EU MDR cov qauv. Cov kev tshuaj xyuas no pab txheeb xyuas qhov tsis sib xws hauv cov txheej txheem, txheeb xyuas cov khoom pov thawj, thiab xyuas kom meej tias txhua yam khoom siv orthodontic ua tau raws li cov kev cai. Cov chaw kho mob uas ua cov kev tshuaj xyuas niaj hnub tuaj yeem daws cov teeb meem muaj peev xwm ua ntej lawv nce mus rau kev txhawj xeeb txog kev cai lij choj lossis kev nyab xeeb.
Txhawm rau ua qhov kev ntsuam xyuas ua tau zoo, cov chaw kho mob yuav tsum ua raws li txoj hauv kev:
- Tsim ib Daim Ntawv Teev Kev Tshawb Fawb: suav nrog thaj chaw tseem ceeb xws li cov ntawv pov thawj khoom, cov ntaub ntawv ua kom tsis muaj menyuam, thiab cov ntaub ntawv qhia cov neeg ua haujlwm.
- Tshawb xyuas cov ntaub ntawv Technical: Xyuas kom tseeb tias tag nrho cov khoom siv orthodontic muaj cov ntaub ntawv soj ntsuam kev soj ntsuam tshiab (CERs) thiab tshaj tawm txog kev ua raws.
- Tshawb xyuas Cov Khoom Muag: Xyuas kom meej tias txhua yam khoom siv nqa tau CE cim thiab ua tau raws li qhov yuav tsum tau ua, xws li Unique Device Identifier (UDI).
- Ntsuas cov txheej txheem: Ntsuas cov txheej txheem ua kom tsis muaj menyuam, cov txheej txheem tswj kev pheej hmoo, thiab kev soj ntsuam tom qab kev ua lag luam.
Tswv yim: Muab ib tug neeg ua raws li txoj cai los saib xyuas cov txheej txheem soj ntsuam. Qhov no ua kom muaj kev lav phib xaub thiab sib luag hauv kev tswj hwm cov qauv kev cai.
Cov ntaub ntawv tseem ceeb sib npaug hauv kev ua kom pom kev ua raws. Cov chaw kho mob yuav tsum muaj cov ntaub ntawv ntxaws ntxaws ntawm kev tshuaj xyuas, suav nrog kev tshawb pom, kev kho kom raug, thiab kev ntsuas ntsuas. Cov ntaub ntawv no ua pov thawj thaum kuaj xyuas los ntawm cov thawj coj tswj hwm. Lawv kuj tseem pab cov tsev kho mob taug qab lawv txoj kev kawm tau raws li EU MDR cov cai.
Kev ua raws li cov ntaub ntawv tau zoo tsis tsuas yog ua kom muaj kev ua raws li txoj cai tab sis kuj tsim kev ntseeg siab rau cov neeg mob. Cov chaw kho mob uas saib xyuas qhov pom tseeb thiab kev lav phib xaub txhawb nqa lub koob npe nrov rau kev saib xyuas zoo. Los ntawm kev sib koom ua ke cov kev tshuaj xyuas tsis tu ncua thiab cov ntaub ntawv ua tiav rau hauv lawv cov haujlwm, cov chaw kho hniav tuaj yeem ntseeg siab txog qhov nyuaj ntawm EU MDR ua raws.
CE-Certified Orthodontic Products ua lub luag haujlwm tseem ceeb hauv kev ua kom cov neeg mob muaj kev nyab xeeb thiab tswj xyuas kev ua raws cai. Cov khoom no ua tau raws li EU MDR cov qauv nruj, uas txhawb nqa qhov zoo thiab kev ntseeg siab ntawm kev kho hniav. Los ntawm kev ua raws li cov cai no, cov chaw kho hniav tuaj yeem tiv thaiv lawv cov neeg mob thiab txhawb kev ntseeg siab rau lawv cov kev pabcuam. Kev ua raws li qhov ua ntej tsis yog tsuas yog ua raws li kev cai lij choj tab sis kuj ua rau pom kev cog lus rau kev ua haujlwm zoo tshaj plaws. Cov chaw kho mob uas lees txais cov kev coj ua no ua rau muaj kev nyab xeeb dua, kev kho hniav zoo dua qub thiab teeb tsa cov qauv ntsuas kom zoo hauv kev lag luam.
FAQ
Dab tsi yog CE kos rau ntawm cov khoom siv orthodontic kos npe?
CovCE cimqhia tias ib yam khoom ua raws li EU kev nyab xeeb, kev noj qab haus huv, thiab ib puag ncig cov qauv. Nws lees paub cov chaw kho hniav thiab cov neeg mob tias cov khoom ua tau raws li kev cai nruj thiab ua tau raws li qhov xav tau.
Tswv yim: Nco ntsoov xyuas cov cim CE thiab cov ntaub ntawv nrog rau ua ntej yuav cov khoom siv orthodontic.
Cov chaw kho hniav yuav ua li cas thiaj ua tau raws li EU MDR?
Cov chaw kho hniav tuaj yeem ua kom muaj kev ua raws cai los ntawm kev txheeb xyuas daim ntawv pov thawj CE, tuav cov ntaub ntawv kom raug, thiab ua cov kev tshuaj xyuas tsis tu ncua. Kev cob qhia cov neeg ua haujlwm ntawm EU MDR cov cai thiab xaiv cov neeg xa khoom muaj npe nrov kuj ua lub luag haujlwm tseem ceeb hauv kev ua raws li cov qauv kev cai.
Puas yog cov khoom muaj ntawv pov thawj CE yuav tsum muaj rau cov chaw kho hniav hauv EU?
Yog lawm, CE-certified cov khoom yog yuav tsum tau rau cov chaw kho hniav nyob rau hauv lub EU. Cov khoom no ua tau raws li cov qauv kev nyab xeeb thiab kev ua tau zoo uas tau teev tseg hauv EU MDR, ua kom cov neeg mob muaj kev nyab xeeb thiab ua raws li txoj cai.
Dab tsi yog Tus Ntaus Ntaus Ntaus Ntaus (UDI), thiab vim li cas nws tseem ceeb?
UDI yog ib txoj cai tshwj xeeb uas tau muab rau cov khoom siv kho mob rau kev taug qab. Nws pab cov tsev kho mob taug qab cov khoom thoob plaws hauv lawv lub neej, ua kom muaj kev tswj xyuas cov khoom muag kom raug thiab kev nyab xeeb ntawm tus neeg mob.
Nco tseg: UDI system yog ib qho tseem ceeb uas yuav tsum tau ua raws li EU MDR.
Ntau npaum li cas cov chaw kho hniav yuav tsum ua raws li kev soj ntsuam xyuas?
Cov chaw kho hniav yuav tsum ua raws li kev soj ntsuam yam tsawg kawg ib xyoos ib zaug. Kev tshuaj xyuas tsis tu ncua pab txheeb xyuas qhov tsis sib xws, txheeb xyuas cov khoom pov thawj, thiab xyuas kom ua raws li EU MDR cov qauv. Kev tshuaj xyuas tsis tu ncua txo kev pheej hmoo thiab tswj kev saib xyuas zoo.
Emoji Ceeb Toom:
Lub sij hawm xa tuaj: Mar-29-2025