Lub lim tiam no peb tau ua kev cob qhia txog MDR cov cai.Hitec Medical tab tom thov MDR daim ntawv pov thawj CE thiab kwv yees kom tau txais nws lub Tsib Hlis tom ntej.

Peb kawm txog txoj kev txhim kho ntawm MDR cov cai.

Thaum Lub Tsib Hlis 5, 2017, Cov Ntawv Xov Xwm Tshaj Tawm ntawm European Union tau tshaj tawm tsab cai lij choj EU Medical Device Regulation (MDR) 2017/745.

Lub hom phiaj ntawm txoj cai no yog kom muaj kev tiv thaiv zoo dua ntawm pej xeem kev noj qab haus huv thiab kev nyab xeeb ntawm cov neeg mob.MDR yuav hloov Cov Lus Qhia 90/385/EEC (Active Implantable Medical Device Directive) thiab 93/42/EEC (Medical Device Directive).Raws li cov cai ntawm MDR Tshooj 123, MDR tau pib siv rau lub Tsib Hlis 26, 2017 thiab hloov pauv MDD (93/42/EEC) thiab AIMDD (90/385/EEC) thaum lub Tsib Hlis 26, 2020.

Vim muaj kev cuam tshuam los ntawm COVID-19, tsab ntawv ceeb toom ntawm kev hloov kho MDR hnub ntawm EU txoj cai tshiab MDR rau lub Plaub Hlis 23, 2020 tau tshaj tawm tias kev siv MDR tau raug ncua mus rau lub Tsib Hlis 26, 2021.

Pib txij lub Tsib Hlis 26, 2021, txhua yam khoom siv kho mob tau tsim tawm tshiab hauv European Union yuav tsum ua raws li MDR cov cai.

Tom qab kev siv MDR, nws tseem tuaj yeem thov rau daim ntawv pov thawj CE raws li MDD thiab AIMDD thaum lub sijhawm hloov pauv peb xyoos thiab tswj xyuas cov ntawv pov thawj siv tau.Raws li Tshooj 120 clause2, daim ntawv pov thawj CE muab los ntawm NB thaum lub sijhawm hloov pauv yuav siv tau, tab sis yuav tsum tsis pub dhau 5 xyoo txij li hnub xa khoom thiab yuav tas rau lub Tsib Hlis 27, 2024.

Tab sis, kev nce qib ntawm MDR tsis tau ua tiav raws li qhov xav tau, thiab txoj cai tam sim no yog raws li hauv qab no,

Ua ntej lub Tsib Hlis 26, 2024, cov tuam txhab yuav tsum xa daim ntawv thov rau MDR rau lawv lub cev ceeb toom, tom qab ntawd lawv daim ntawv pov thawj MDD (IIb, IIa, thiab I khoom siv) tuaj yeem txuas ntxiv mus txog Lub Kaum Ob Hlis 31, 2028.