Nrog rau qhov xaus ntawm lub sijhawm hloov pauv raws li EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR, Txoj Cai (EU) 2017/745), txoj cai tam sim no tau nkag mus rau nws.tag nrho txoj cai theem. Raws li kev tswj hwm kev txhim kho no, cov ntaub ntawv kho hniav prosthetic tau qhia meej meej raws liClass IIa cov khoom siv kho mob, txhais tau hais tias tag nrho cov khoom zoo li no npaj rau lub lag luam EU yuav tsum tuav tauMDR{0}}CE daim ntawv pov thawjmuab los ntawm Lub Tsev Haujlwm Saib Xyuas Kev Pom Zoo thiaj li yuav muab tso rau hauv kev ua lag luam raug cai.

I. Kev tswj hwm keeb kwm yav dhau: Ib qho keeb kwm Leap ntawm MDD mus rau MDR

EU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR) tau tshaj tawm thaum lub Tsib Hlis 2017, hloov Cov Lus Qhia Txog Kev Kho Mob (MDD, 93/42/EEC) uas tau siv rau ze li peb xyoos lawm. Piv nrog rau cov lus qhia qub, MDR tau nruj nruj raws li cov cai ntawm kev faib cov cuab yeej, cov ntaub ntawv pov thawj kho mob, tom qab- kev soj ntsuam kev lag luam, Cim Cim Cim Cim Cim Cim (UDI), thiab nruj ntawm Kev Ntsuas Lub Cev.

Tom qab xyoo ntawm kev hloov pauv hloov pauv, MDR tam sim no tau nkag mus rau ib qhotheem ntawm kev yuam kom tag nrho. Cov khoom lag luam yav dhau los tso siab rau MDD daim ntawv pov thawj "txuas ntxiv" lossis "lub sijhawm muaj txiaj ntsig" cov kev cai yuav tsum ua kom tiav lawv cov kev hloov pauv ntawm MDR raws li lub sijhawm teem tseg, lossis raug tshem tawm ntawm EU kev ua lag luam.

II. Cov Khoom Siv Kho Hniav Cov Khoom Siv Kho Hniav: Cov Chav Kawm IIa txhais li cas

Raws li kev faib tawm cov cai tau teev tseg hauv Annex VIII ntawm MDR, cov khoom siv kho hniav - suav nrog tab sis tsis txwv rau zirconia blocks, iav ceramics (xws li Emax), resin cov ntaub ntawv yas ib ntus, cov ntaub ntawv kho hniav hloov tau, cov khoom siv cog hniav, thiab cov khoom siv sib txuas ntxiv - poob rau hauvClass IIa cov khoom siv kho mob.

Qhov kev faib tawm no muaj qhov cuam tshuam hauv qab no:

Yuav Tsum Tau Ceeb Toom Kev Ntsuas Lub Cev: Tsis zoo li cov khoom siv hauv chav kawm I (uas tej zaum yuav yog tus kheej- tau tshaj tawm), Class IIa cov khoom yuav tsum muaj kev ntsuas kev ua raws li EU- tau lees paub Lub Cev Ceeb Toom. Cov neeg tsim khoom tsis tuaj yeem ua tus kheej - tshaj tawm ua raws.

Tseem ceeb dua cov ntaub ntawv pov thawj kho mob: Cov neeg tsim khoom yuav tsum muab cov ntaub ntawv pov thawj kho mob zoo, suav nrog cov ntaub ntawv kho mob, kev tshuaj xyuas cov ntaub ntawv, lossis kev soj ntsuam kuaj mob, los ua kom pom cov khoom muaj kev nyab xeeb thiab kev ua tau zoo.

Technical Documentation yuav raug ceeb toom lub cev tshuaj xyuas: Cov ntaub ntawv yuav tsum npog cov khoom tsim, kev tswj hwm kev pheej hmoo (ISO 14971), biocompatibility (ISO 10993), sterilization validation, labeling, thiab cov lus qhia rau kev siv.

Tom qab-Kev Tshawb Fawb Kev Lag Luam (PMS) thiab Daim Ntawv Qhia Txog Kev Nyab Xeeb Kev Nyab Xeeb (PSUR) dhau los ua cov luag haujlwm raug cai.

III. Ceeb Toom Lub Cev MDR-CE Certification: "Passport" rau EU Market

Raws li MDR lub moj khaum, aCeeb Toom Lub Cevyog ib lub koom haum thib peb -txoj kev ntsuam xyuas kev ua raws cai los ntawm EU Tus Tswvcuab Lub Xeev thiab tau lees paub los ntawm European Commission. Tsuas yog CE daim ntawv pov thawj uas tau muab los ntawm Lub Tsev Teev Ntuj Ceeb Toom uas tuav txoj cai MDR raug lees paub los ntawm EU cov neeg saib xyuas kev lag luam.

Kev lag luam tam sim no ntsib ntau yam kev sib tw:

Scarce ceeb toom lub cev muaj peev xwm: Tus naj npawb ntawm Cov Ntawv Ceeb Toom nrog MDR tsim thiab kho hniav - kev tshawb xyuas cov haujlwm tsuas yog txwv, thiab cov npe tos yog ntev - nyob rau qee kis txuas ntxiv ob peb lub hlis mus rau ntau tshaj ib xyoos.

Cov qauv ntsuas nruj dua: Kev ceeb toom lub cev kev tshuaj xyuas nyob rau hauv MDR yog qhov tob thiab dav dua li hauv MDD. Cov ntaub ntawv pov thawj kho mob tsis txaus, kev tswj hwm tsis txaus, lossis cov ntaub ntawv tsis raug cai tuaj yeem ua rau qhov kev ntsuas ua tsis tiav.

Daim ntawv pov thawj conversion siab: Cov khoom uas tuav daim ntawv pov thawj MDD qub yuav tsum tau txais MDR rov- ntawv pov thawj nyob rau hauv lub qhov rais hloov. Cov uas tsis hloov pauv raws sijhawm yuav poob lawv txoj cai nyob hauv EU kev ua lag luam.

IV. Kev cuam tshuam thiab teb rau cov kws kho hniav

Rau kev kho hniav OEM / ODM cov tuam txhab uas tso siab rau EU ua lub lag luam xa tawm tseem ceeb, tag nrho kev tswj hwm ntawm MDR muaj nyob deb - mus txog qhov tshwm sim:

Ua kom muaj kev lag luam ntau dua kev cuam tshuam: Yog tsis muaj MDR siv tau- daim ntawv pov thawj CE, cov khoom tsis tuaj yeem nkag mus rau 27 EU Cov Tswv Cuab, thiab lawv tsis tuaj yeem tshem tawm kev lis kev cai los ntawm European Economic Area (EEA).

Qhov tseem ceeb nce nqi kev ua raws cai: Kev ceeb toom cov nqi ntsuas lub cev, kev soj ntsuam kuaj mob, kev npaj cov ntaub ntawv thev naus laus zis, thiab kev txhim kho kev tswj hwm zoo (ISO 13485) txhua tus yuav tsum muaj nyiaj txiag thiab tib neeg cov peev txheej.

Accelerating mov saw consolidation: Cov lag luam me thiab nruab nrab- cov lag luam loj tuaj yeem tawm hauv EU ua lag luam vim tsis muaj nqi ua raws cai, thaum cov peev txheej kev lag luam tsom mus rau cov thawj coj uas muaj peev xwm ua tau raws li kev ua tau zoo.

Txhim kho hom kev ntseeg siab: Cov tuam txhab tuav MDR-CE daim ntawv pov thawj yuav tau txais kev ntseeg ntau dua los ntawm cov kws kho hniav nyob sab Europe thiab cov koom tes faib khoom, ua rau daim ntawv pov thawj muaj zog sib txawv hauv kev sib tw.

Cov kws tshaj lij hauv kev lag luam pom zoo tias cov tuam txhab cuam tshuam tau pib ua raws li MDR cov phiaj xwm kom sai li sai tau, ua qhov tseem ceeb tshaj tawm Cov Ntawv Ceeb Toom nrog cov ntaub ntawv pov thawj kev kho hniav- cov kev paub dhau los, tsim kom muaj kev tswj xyuas zoo, thiab kho cov kev soj ntsuam kev soj ntsuam thiab kev npaj cov ntaub ntawv raws li qhov tseem ceeb ntawm cov tswv yim tseem ceeb.

V. Xaus

Kev tswj hwm tag nrho ntawm EU MDR yog qhov pib ntawm lub sijhawm tshiab hauv kev tswj hwm kev kho mob thoob ntiaj teb - ib qho txhais los ntawm kev saib xyuas nruj dua thiab tus neeg mob -kev nyab xeeb- thawj txoj hauv kev. Raws li Class IIa cov cuab yeej kho mob, cov khoom siv kho hniav tsis muaj kev xaiv los kho MDR-CE daim ntawv pov thawj raws li kev txiav txim siab; nws tau ua ibyuav tsum preconditionrau EU kev lag luam nkag. Rau cov tuam txhab kho hniav tau koom nrog hauv kev lag luam nyob sab Europe, ua kom muaj kev ua raws cai thiab ua tiav daim ntawv pov thawj ua ntej ntawm lub sijhawm tsis yog qhov tseem ceeb rau kev khaws cov khoom lag luam, tab sis kuj yog tus yuam sij kom muaj kev sib tw kom zoo dua hauv kev hloov pauv kev lag luam tom ntej.