Txhawm rau ua lag luam cov cuab yeej siv kho mob hauv European Union, yuav tsum muaj daim ntawv pov thawj CE Mark. Daim ntawv pov thawj no txheeb xyuas tias lub cuab yeej ua tau raws li txhua txoj cai tswj hwm rau cov cuab yeej siv kho mob, uas yuav hloov pauv sai raws li Txoj Cai Kev Kho Mob Tshiab (MDR 2017/745). Yog xav paub ntxaws ntxiv ntawm European txoj cai tswj hwm rau cov cuab yeej siv kho mob hauv MDR, rub daim duab hauv qab no.
European CE pom zoo cov cuab yeej kho mob txheej txheem piav qhia
Daim duab qhia qhia txog txheej txheem pom zoo CE hauv Tebchaws Europe thiab muaj rau rub tawm hauv PDF hom ntawv. Txawm li cas los xij, yog tias koj xav piav qhia cov kauj ruam rau lwm tus neeg hauv email, koj tuaj yeem txiav thiab muab cov ntawv hauv qab no lossis xa lawv txuas rau nplooj ntawv no.
Kauj ruam 1
Txhawm rau kom tau txais Daim Ntawv Pov Thawj CE, koj yuav tsum ua raws European Commission Regulation (EU) No. 2017/745, feem ntau hu ua Medical Device Regulation (MDR).
Kauj ruam 2
Teem Ib Tus Neeg Lij Choj rau kev ua raws txoj cai. Txiav txim siab kev faib tawm ntawm koj lub cuab yeej siv Annex VIII (Classification Criteria) ntawm MDR - Class I (tus kheej -ntawv pov thawj); Chav Kawm I (tsis muaj menyuam, ntsuas ntsuas lossis rov siv lub cuab yeej phais); Class IIa, Class IIb, lossis Class III.
Kauj ruam 3
Rau txhua lub cuab yeej tshwj tsis yog Chav Kawm I (tus kheej-ntawv pov thawj), siv Kev Tswj Xyuas Zoo (QMS) raws li MDR. Feem ntau cov tuam txhab siv EN ISO 13485 tus qauv kom ua tiav kev ua raws. Koj QMS yuav tsum suav nrog Kev Ntsuam Xyuas Kev Kho Mob, Kev Saib Xyuas Tom Qab Kev Ua Lag Luam (PMS) thiab Kev Tshawb Fawb Kev Tshawb Fawb Tom Qab Kev Ua Lag Luam (PMCF). Npaj nrog cov neeg xa khoom txog qhov tsis tau tshaj tawm ceeb toom Lub Cev Kev Ntsuam Xyuas.
Rau Chav Kawm I (tus kheej-ntawv pov thawj), koj yuav tsum siv QMS txawm hais tias ceeb toom lub cev kev cuam tshuam tsis xav tau.
Kauj ruam 4
Raws li Annex II thiab III, npaj CE Cov Ntaub Ntawv lossis Tsim Dossier (Chav III) muab cov ntaub ntawv hais txog koj lub cuab yeej thiab nws lub hom phiaj siv ntxiv rau kev tshuaj xyuas cov ntawv ceeb toom, Kev tshuaj ntsuam xyuas soj ntsuam (CER), cov ntaub ntawv tswj kev pheej hmoo, IFU, labeling thiab ntau ntxiv. Tau Txais Cov Cim Cim Cim (UDI) rau koj lub cuab yeej. Txhua lub cuab yeej, txawm tias yog cov khoom qub uas tau siv rau ntau caum xyoo, yuav xav tau cov ntaub ntawv kho mob. Feem ntau ntawm cov ntaub ntawv no yuav tsum xa mus rau cov khoom siv. Cov kev tshawb fawb soj ntsuam feem ntau xav tau rau kev hloov pauv thiab chav kawm III cov cuab yeej. Cov ntaub ntawv kho mob uas twb muaj lawm tej zaum yuav siv tau. Kev soj ntsuam kuaj mob hauv Tebchaws Europe yuav tsum tau pom zoo ua ntej los ntawm European Competent Authority.
Kauj ruam 5
Yog tias koj tsis muaj chaw nyob hauv Tebchaws Europe, xaiv Tus Neeg Sawv Cev Tso Cai (EC REP) nyob hauv EU uas tsim nyog los daws teeb meem kev tswj hwm. Muab koj lub npe EC REP thiab chaw nyob rau ntawm daim ntawv lo khoom. Tau Txais Ib Tus Zauv Sau Npe los ntawm cov tswj hwm.
Kauj ruam 6
Rau txhua lub cuab yeej tshwj tsis yog Chav Kawm I (tus kheej-ntawv pov thawj), koj li QMS thiab Cov Ntaub Ntawv lossis Tsim Dossier yuav tsum tau tshuaj xyuas los ntawm Lub Cev Ceeb Toom, ib tus neeg thib peb tau lees paub los ntawm European cov cai los tshuaj xyuas cov tuam txhab kho mob thiab cov khoom lag luam.
Kauj ruam 7
Rau txhua lub cuab yeej tshwj tsis yog Chav Kawm I (tus kheej-ntawv pov thawj), koj yuav tau txais daim ntawv pov thawj European CE Cim rau koj lub cuab yeej thiab daim ntawv pov thawj ISO 13485 rau koj lub chaw tom qab ua tiav qhov kev ceeb toom koj lub cev tshuaj xyuas. Daim ntawv pov thawj ISO 13485 yuav tsum rov ua dua tshiab txhua xyoo. Cov Ntawv Pov Thawj CE yog feem ntau siv tau ntev txog 5 xyoos, tab sis feem ntau tau tshuaj xyuas thaum lub sijhawm koj tshuaj xyuas txhua xyoo.
Kauj ruam 8
Npaj Daim Ntawv Tshaj Tawm ntawm Kev Ua Raws raws li Annex IV, daim ntawv cog lus raug cai tau npaj los ntawm cov chaw tsim khoom hais tias lub cuab yeej ua tau raws li cov kev cai nyob sab Europe. Tam sim no koj tuaj yeem sau cim CE.
Kauj ruam 9
Sau npe lub cuab yeej thiab nws Cov Cim Cim Cim Cim (UDI) hauv EUDAMED database. UDI yuav tsum yog daim ntawv lo thiab cuam tshuam nrog cov ntaub ntawv tswj hwm.
Kauj ruam 10
Rau Chav Kawm I (tus kheej-ntawv pov thawj), tsis tas yuav tshawb xyuas NB txhua xyoo. Txawm li cas los xij, CER, Cov Ntaub Ntawv Txuj Ci, thiab PMS cov haujlwm yuav tsum tau khaws cia tshiab.
Rau tag nrho lwm cov chav kawm, koj yuav raug tshuaj xyuas txhua xyoo los ntawm Lub Cev Ceeb Toom kom ntseeg tau tias ua raws li MDR txuas ntxiv mus. Kev tsis ua tiav qhov kev tshuaj xyuas yuav ua rau koj daim ntawv pov thawj CE kos npe tsis raug. Koj yuav tsum ua qhov Kev Ntsuam Xyuas Kuaj Mob, PMS, thiab PMCF cov haujlwm kom muaj ntawv pov thawj.
Nov yog qhov txheej txheem piav qhia yooj yim ntawm cov txheej txheem. Koj Lub Cev Ceeb Toom tuaj yeem xaiv los tshuaj xyuas koj li kev xa thiab thov ntau cov ntaub ntawv, uas yuav ntxiv sijhawm rau koj kev pom zoo.