Thaum cov khoom siv kho mob nkag mus rau European lag luam, lawv feem ntau yuav tsum tau xeem ntawv pov thawj CE. Cov lus qhia hauv vitro diagnostic kho mob cov lus qhia (in vitro diagnostic kho mob cov lus qhia (98/79/EC), tom qab no hu ua IVDD), uas yog Ameslikas ua raws li CE daim ntawv pov thawj, yuav raug rau lub in vitro diagnostic kho mob cov kev cai (hauv vitro diagnostic medical device) txij lub Tsib Hlis 26, 2022. Txoj Cai (EU) 2017/746, hereinafter hu ua IVDR).
Ib qho kev hloov pauv tseem ceeb hauv kev hloov pauv ntawm IVDD mus rau IVDR yog tias ntau qhov kev ntsuam xyuas ntawm IVD cov khoom lag luam yuav tsum muaj kev koom tes ntawm lub cev ceeb toom. Tam sim no, tsuas yog ib qho me me ntawm cov khoom lag luam uas muaj kev pheej hmoo siab (kwv yees li 8 feem pua ntawm IVDs ntawm lub khw) yuav tsum tau xa mus rau Lub Tsev Haujlwm Saib Xyuas Kev Ceeb Toom rau kev tshuaj xyuas raws li qhov xav tau los ntawm IVDD. Tom qab kev siv IVDR, kwv yees li 80 feem pua ntawm cov tshuaj ntsuam xyuas hauv vitro yuav tsum tau tshuaj xyuas los ntawm lub cev ceeb toom.
Ntxiv rau CE ntawm Class A cov khoom lag luam, uas tuaj yeem tso npe rau hauv European Union, European tiam, thiab IVDR cov ntaub ntawv kev ua raws txoj kev, CE ntawm Class B, C, thiab D txhua yam yuav tsum tau lees paub los ntawm lub cev ceeb toom. Tam sim no, tsuas muaj 5 lub cev ceeb toom uas tau txais IVDR. , thiab cov ntawv ceeb toom no tseem tsis tau npaj los lees txais IVDR cov teeb meem vim yog cov neeg ua haujlwm tsim nyog thiab lwm yam teeb meem.
Txawm hais tias nws yog cov khoom siv tshuaj tiv thaiv kab mob coronavirus tshiab, cov khoom siv kuaj pom tus mob coronavirus tshiab, lossis cov khoom siv kuaj mob coronavirus tshiab, raws li kev faib tawm cov cai ntawm Cov Lus Qhia 98/79 / EC, nws yog siv rau kev kuaj mob tshiab tus mob coronavirus siv. los ntawm cov kws tshaj lij. Reagents yog cov khoom lag luam sab nraud ntawm Daim Ntawv Teev Npe A thiab Daim Ntawv Teev Npe B. Nws cov txheej txheem ua raws CE yog kev tshaj tawm ntawm kev ua raws, suav nrog kev npaj cov ntaub ntawv kev lag luam, kos npe rau daim ntawv tshaj tawm kev ua raws, kev xaiv los ntawm EU tso cai sawv cev, thiab ua tiav. ntawm EU tus tswv cuab lub xeev muaj peev xwm sau npe los ntawm EU tus neeg sawv cev tso cai.