commiss decis common technic specif vitro diagnost medic devic notifi document number text eea relev ec commiss european commun regard treati establish european commun regard direct ec european parliament council octob vitro diagnost medic devic subparagraph articl thereof direct ec set essenti requir vitro diagnost medic devic meet market conform harmonis standard presumpt conform relev essenti requir except gener principl draw common technic specif take account current practic member state select devic evalu safeti blood suppli organ donat specif adopt public author common technic specif perform evalu evalu scientif expert interest parti involv draft common technic specif direct ec member state presum complianc essenti requir respect devic design manufactur conform common technic specif drawn devic highest risk categori specif establish perform evalu evalu criteria batch releas criteria refer method refer materi manufactur gener rule requir compli common technic specif duli justifi reason manufactur compli specif adopt solut level equival thereto measur provid decis accord opinion committe set articl council direct eec adopt decis articl technic specif set annex decis adopt common technic specif vitro diagnost medic devic list annex ii direct ec articl decis address member state brussel commiss erkki liikanen member commiss oj oj annex ct common technic specif vitro diagnost medic devic scope common technic specif list devic refer annex ii list reagent reagent product includ relat calibr control materi determin blood group abo system rhesu anti kell reagent reagent product includ relat calibr control materi detect confirm quantif human specimen marker hiv infect hiv htlv ii hepat definit diagnost sensit probabl devic posit result presenc target marker true posit specimen posit target marker correctli classifi devic fals neg specimen posit target marker misclassifi devic diagnost specif probabl devic neg result absenc target marker fals posit specimen neg target marker misclassifi devic true neg specimen neg target marker correctli classifi devic analyt sensit context ct express limit detect smallest amount target marker precis detect analyt specif abil method determin sole target marker nucleic acid ampif techniqu nat context document term quot nat quot test detect quantif nucleic acid amplif target sequenc amplif signal hybridis rapid test context term quot rapid test quot understood test singli small seri design give rapid result patient test robust robust analyt procedur measur capac remain unaffect small deliber variat method paramet indic reliabl normal usag system failur rate system failur rate frequenc failur entir process perform prescrib manufactur common technic specif ct product defin annex ii list direct ec ct perform evalu reagent reagent product detect confirm quantif human specimen marker hiv infect hiv htlv ii hepat gener principl devic detect viru infect market screen diagnost test meet requir sensit specif tabl devic intend manufactur test bodi fluid serum plasma urin saliva meet ct requir sensit specif serum plasma test perform evalu test sampl individu test approv respect serum plasma assai devic intend manufactur test home meet ct requir sensit specif respect devic profession relev part perform evalu carri repeat lai user valid oper devic instruct perform evalu carri direct comparison establish devic accept perform ce mark ivd establish devic comparison ce mark market time perform evalu discrep test result identifi part evalu result resolv evalu discrep sampl test system altern method marker review clinic statu diagnosi patient test follow sampl perform evalu perform popul equival european popul posit specimen perform evalu select reflect stage respect diseas antibodi pattern genotyp subtyp blood screen devic except hbsag test true posit sampl identifi posit devic ce mark tabl hbsag test devic perform equival establish devic principl diagnost test sensit earli infect phase sero convers repres state art test addit sero convers panel conduct notifi bodi manufactur result confirm initi perform evalu data tabl neg specimen perform evalu defin reflect target popul test intend blood donor hospitalis patient pregnant women perform evalu screen assai tabl blood donor popul investig blood donat centr consist consecut blood donat select exclud time donor devic specif blood donat accompani tabl specif calcul frequenc repeatedli reactiv fals posit result blood donor neg target marker devic evalu establish effect potenti interf substanc part perform evalu potenti interf substanc evalu depend extent composit reagent configur assai potenti interf substanc identifi part risk analysi requir essenti requir devic includ specimen repres quot relat quot infect specimen multipara women pregnanc rheumatoid factor posit patient recombin antigen human antibodi compon express system anti coli anti yeast devic intend manufactur serum plasma perform evalu demonstr serum plasma equival demonstr donat devic intend plasma perform evalu verifi perform devic anticoagul manufactur devic demonstr donat part requir risk analysi system failur rate lead fals neg result determin repeat assai low posit specimen addit requir nucleic acid amplif techniqu nat perform evalu criteria nat assai found tabl target sequenc amplif assai function control test sampl intern control reflect state art control process extract amplif hybridis detect analyt sensit detect limit nat assai express posit cut analyt concentr test run give posit result serial dilut intern refer materi standard calibr refer materi genotyp detect demonstr primer probe design valid valid test characteris genotyp sampl result quantit nat assai traceabl intern standard calibr refer materi express intern unit utilis specif field applic nat assai detect viru antibodi neg sampl pre sero convers sampl virus immun complex behav differ comparison free virus centrifug step import robust studi antibodi neg pre sero convers sampl includ investig potenti carri run altern high posit neg specimen perform robust studi high posit sampl compris sampl natur occur high viru titr system failur rate lead fals neg result determin test low posit specimen low posit specimen viru concentr equival posit cut viru concentr ct manufactur releas test reagent reagent product detect confirm quantif human specimen marker hiv infect hiv htlv ii hepat immunolog assai manufactur releas test criteria ensur batch consist identifi relev antigen epitop antibodi manufactur batch releas test includ specimen neg relev analyt ct perform evalu reagent reagent product determin blood group antigen abo system rhesu kell criteria perform evalu reagent reagent product determin blood group abo system rhesu kell found tabl perform evalu carri direct comparison establish devic accept perform ce mark ivd establish devic comparison ce mark market time perform evalu discrep test result identifi part evalu result resolv evalu discrep sampl test system altern method perform evalu perform popul equival european popul posit specimen perform evalu select reflect variant weak antigen express devic evalu establish effect potenti interf substanc part perform evalu potenti interf substanc evalu depend extent composit reagent configur assai potenti interf substanc identifi part risk analysi requir essenti requir devic devic intend plasma perform evalu verifi perform devic anticoagul manufactur devic demonstr donat ct manufactur releas test reagent reagent product determin blood group antigen abo system rhesu kell manufactur releas test criteria ensur batch consist identifi relev antigen epitop antibodi requir manufactur batch releas test outlin tabl tabl quot screen quot assai anti hiv anti htlv ii anti hcv hbsag anti hbc gt tabl gt tabl nat assai hiv hcv hbv htlv ii qualit quantit molecular type gt tabl gt nota accept criteria quot system failur rate lead fals neg result quot assai posit tabl rapid test anti hiv anti hcv hbsag anti hbc anti htlv ii gt tabl gt tabl confirmatori supplementari assai anti hiv anti htlv ii anti hcv hbsag gt tabl gt tabl hiv antigen gt tabl gt tabl serotyp assai hcv gt tabl gt tabl hbv marker anti hb anti hbc igm anti hbe hbeag gt tabl gt tabl hdv marker anti hdv anti hdv igm delta antigen gt tabl gt tabl blood group abo rhesu kell gt tabl gt tabl batch releas criteria blood group abo rhesu kell specif test requir reagent test reagent gt pic file quot en tif quot gt accept criteria batch reagent exhibit unequivoc posit neg result recommend techniqu accord result obtain perform evalu data control materi red cell phenotyp red cell control blood type reagent list confirm establish devic