direct ec european parliament council octob vitro diagnost medic devic european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur laid articl treati measur adopt smooth oper intern market intern market area intern frontier free movement good person servic capit ensur content scope law regul administr provis forc member state regard safeti health protect perform characterist authoris procedur vitro diagnost medic devic exist dispar creat barrier trade establish harmonis rule confirm compar survei nation legisl carri behalf commiss harmonis nation legisl mean remov barrier free trade prevent barrier aris object achiev satisfactori manner mean individu member state direct lai requir suffici ensur safeti condit free movement vitro diagnost medic devic appli harmonis provis distinguish measur adopt member state manag fund public health sick insur scheme relat directli indirectli devic harmonis provis affect abil member state implement measur provid compli commun law vitro diagnost medic devic provid patient user parti high level health protect attain perform level origin attribut manufactur mainten improv level health protect attain member state main object direct accord principl set council resolut approach technic harmonis standard rule design manufactur packag relev product confin provis requir meet essenti requir essenti requir replac nation provis essenti requir includ requir minimis reduc risk appli discret take account technolog practic time design technic econom consider compat high level protect health safeti major part medic devic cover council direct eec june approxim law relat activ implant medic devic council direct eec june medic devic exclus vitro diagnost medic devic direct seek extend harmonis vitro diagnost medic devic interest uniform commun rule direct base larg provis direct instrument apparatu applianc materi articl includ softwar intend research purpos medic object regard devic perform evalu internation certifi refer materi materi extern qualiti assess scheme cover direct calibr control materi need user establish verifi perform devic vitro diagnost medic devic regard principl subsidiar reagent produc health institut laboratori environ subject commercialtransact cover direct devic manufactur intend profession commerci context purpos medic analysi market subject direct mechan laboratori equip design vitro diagnost examin fall scope direct order harmonis relev direct direct ec european parliament council june approxim law member state relat machineri appropri amend bring line direct direct includ requir design manufactur devic emit ioniz radiat direct affect applic council direct euratom lai basic safeti standard protect health worker gener public danger aris ionis radiat electromagnet compat aspect form integr part essenti requir direct council direct eec approxim law member state relat electromagnet compat appli order eas task prove conform essenti requir enabl conform verifi desir harmonis standard respect prevent risk design manufactur packag medic devic harmonis standard drawn privat law bodi retain statu mandatori text end european committe standardis cen european committe electrotechn standardis cenelec recognis compet bodi adopt harmonis standard accord gener guidelin cooper commiss bodi sign novemb purpos direct harmonis standard technic specif european standard harmonis document adopt mandat commiss cen cenelec bodi accord direct ec european parliament council june lai procedur provis inform field technic standard regul pursuant abovement gener guidelin 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 specif replac common technic specif common technic specif perform evalu reevalu scientif expert interest parti involv draft common technic specif examin specif gener question manufactur cover direct includ packag medic devic packag relat safeti perform aspect devic devic limit life ow declin perform time relat deteriori physic chemic properti includ steril integr packag manufactur determin period devic perform intend label date devic compon complet safeti decis eec juli modul phase conform assess procedur rule affix ce conform mark intend technic harmonis direct council laid harmonis conform assess procedur detail ad modul justifi natur verif requir vitro diagnost medic devic consist direct eec eec essenti purpos conform assess procedur group vitro diagnost medic devic main product class larg major devic constitut direct risk patient compet train profession result obtain confirm mean conform assess procedur carri gener rule sole respons manufactur take account exist nation regul notif receiv procedur laid direct ec intervent notifi bodi need defin devic correct perform essenti medic practic failur risk health vitro diagnost medic devic intervent notifi bodi requir group product blood transfus prevent aid type hepat requir conform assess guarante view design manufactur optimum level safeti reliabl list vitro diagnost medic devic subject parti conform assess updat take account technolog progress develop field health protect updat measur line procedur iii laid council decis eec juli lai procedur exercis implement power confer commiss agreement modu vivendi european parliament council commiss implement measur act adopt accord procedur laid articl treati reach decemb medic devic gener rule bear ce mark indic conform provis direct enabl move freeli commun put servic accord intend purpos manufactur intervent notifi bodi requir choos list bodi publish commiss member state oblig design notifi bodi ensur bodi design notifi bodi compli assess criteria laid direct director staff notifi bodi intermediari interest establish subject assess verif compromis independ compet author charg market surveil emerg contact manufactur authoris repres establish commun order protect measur prove cooper exchang inform member state view uniform applic direct purpos market surveil end establish manag databas data manufactur authoris repres devic market certif issu suspend withdrawn vigil procedur system advers incid report vigil procedur constitut tool surveil market includ perform devic inform obtain vigil procedur extern qualiti assess scheme decis make classif devic essenti manufactur notifi compet author place market product regard technolog substanc analys paramet true high densiti dna probe devic micro chip genet screen member state consid product group product order protect health safeti ensur complianc imper public health accord articl treati prohibit restrict avail subject special condit transit measur justifi case commiss consult interest parti member state nation measur justifi adopt commun measur accord procedur iii laid decis eec direct cover vitro diagnost medic devic manufactur tissu cell substanc human origin refer medic devic manufactur substanc human origin work continu connect order produc commun legisl view protect integr human person sampl collect substanc deriv human bodi appli principl laid convent council europ protect human right digniti human regard applic biologi medicin nation regul relat ethic continu appli interest consist direct medic devic provis direct incorpor direct eec amend draw quickli legisl lack medic devic manufactur substanc human origin adopt direct articl scope definit direct appli vitro diagnost medic devic accessori purpos direct accessori treat vitro diagnost medic devic vitro diagnost medic devic accessori hereinaft term devic purpos direct definit appli medic devic mean instrument apparatu applianc materi articl combin includ softwar proper applic intend manufactur human be purpos diagnosi prevent monitor treatment allevi diseas diagnosi monitor treatment allevi compens injuri handicap investig replac modif anatomi physiolog process control concept achiev princip intend action human bodi pharmacolog immunolog metabol mean assist function mean vitro diagnost medic devic mean medic devic reagent reagent product calibr control materi kit instrument apparatu equip system combin intend manufactur vitro examin specimen includ blood tissu donat deriv human bodi sole princip purpos provid inform physiolog patholog state congenit abnorm determin safeti compat potenti recipi monitor therapeut measur specimen receptacl consid vitro diagnost medic devic specimen receptacl devic vacuum type specif intend manufactur primari contain preserv specimen deriv human bodi purpos vitro diagnost examin product gener laboratori vitro diagnost medic devic product view characterist specif intend manufactur vitro diagnost examin accessori mean articl whilst vitro diagnost medic devic intend specif manufactur devic enabl devic accord intend purpos purpos definit invas sampl devic directli appli human bodi purpos obtain specimen mean direct eec consid accessori vitro diagnost medic devic devic test mean devic intend manufactur lai person home environ devic perform evalu mean devic intend manufactur subject perform evalu studi laboratori medic analys environ premis manufactur mean natur legal person respons design manufactur packag label devic market oper carri person behalf parti oblig direct met manufactur appli natur legal person assembl packag process fulli refurbish label readi made product assign intend purpos devic view market subparagraph appli person manufactur mean subparagraph assembl adapt devic market intend purpos individu patient authoris repres mean natur legal person establish commun explicitli design manufactur act address author bodi commun manufactur regard oblig direct intend purpos mean devic intend data suppli manufactur label instruct promot materi place market mean make return payment free charg devic devic intend perform evalu view distribut commun market fulli refurbish put servic mean stage devic made final user readi commun market time intend purpos purpos direct calibr control materi refer substanc materi articl intend manufactur establish measur relationship verifi perform characterist devic conjunct intend devic purpos direct remov collect tissu cell substanc human origin govern relat ethic principl laid convent council europ protect human right digniti human regard applic biologi medicin member state regul matter direct appli devic manufactur health institut premis manufactur premis vicin transfer legal entiti affect member state subject activ protect requir direct affect nation law provid suppli devic medic prescript direct specif direct mean articl direct eec ceas appli devic compli direct articl place market put servic member state step ensur devic market put servic compli requir laid direct duli suppli properli instal maintain accord intend purpos involv oblig member state monitor secur qualiti devic articl appli devic made perform evalu articl essenti requir devic meet essenti requir set annex appli take account intend purpos devic concern articl free movement member state creat obstacl place market put servic territori devic bear ce mark provid articl devic undergon conform assess accord articl member state creat obstacl devic intend perform evalu made purpos laboratori institut list statement refer annex viii meet condit laid articl annex viii trade fair exhibit demonstr scientif technic gather member state creat obstacl show devic conform direct provid devic specimen particip visibl sign devic market put servic made compli member state requir inform suppli pursuant annex part section offici languag devic reach final user provid safe correct devic ensur member state authoris inform refer subparagraph offici commun languag applic provis member state account principl proportion inform suppli harmonis symbol recognis code measur type user anticip devic devic subject direct aspect provid affix ce mark devic fulfil provis direct direct manufactur transit period choos arrang appli ce mark devic fulfil provis direct appli manufactur case particular direct publish offici journal european commun document notic instruct requir direct accompani devic articl refer standard member state presum complianc essenti requir refer articl respect devic conform relev nation standard transpos harmonis standard refer number publish offici journal european commun member state publish refer number nation standard member state commiss consid harmonis standard meet essenti requir refer articl measur member state regard standard public refer paragraph articl adopt procedur defin articl member state presum complianc essenti requir refer articl respect devic design manufactur conform common technic specif drawn devic list annex ii devic list annex ii specif establish perform evalu evalu criteria batch releas criteria refer method refer materi common technic specif adopt accord procedur mention articl publish offici journal european commun manufactur gener rule requir compli common technic specif duli justifi reason manufactur compli specif adopt solut level equival thereto direct refer made harmonis standard meant refer common technic specif articl committe standard technic regul commiss assist committe set articl direct ec repres commiss submit committe draft measur committe deliv opinion draft time limit chairman lai urgenc matter take vote opinion record minut addit member state posit record minut commiss utmost account opinion deliv committe inform committe manner opinion account articl committe medic devic commiss assist committe set articl direct eec repres commiss submit committe draft measur committe deliv opinion draft time limit chairman lai urgenc matter opinion deliv major laid articl treati case decis council requir adopt propos commiss vote repres member state committe weight manner set articl chairman vote commiss adopt measur envisag accord opinion committe measur envisag accord opinion committe opinion deliv commiss delai submit council propos relat measur council act qualifi major expiri period month date referr council council act propos measur adopt commiss committe refer paragraph examin question connect implement direct articl safeguard claus member state ascertain devic refer articl correctli instal maintain intend purpos compromis health safeti patient user applic person safeti properti interim measur withdraw devic market prohibit restrict market put servic member state immedi inform commiss measur indic reason decis complianc direct due failur meet essenti requir refer articl incorrect applic standard refer articl claim standard appli shortcom standard commiss enter consult parti concern consult commiss find measur justifi immedi inform member state initi member state decis refer paragraph attribut shortcom standard commiss consult parti concern bring matter committe refer articl month member state decis intend maintain initi procedur refer articl measur refer paragraph attribut problem relat content applic common technic specif commiss consult parti concern bring matter committe refer articl month measur unjustifi immedi inform member state initi manufactur authoris repres compli devic bear ce mark compet member state action whomsoev affix mark inform commiss member state thereof commiss ensur member state inform progress outcom procedur articl conform assess procedur devic cover annex ii devic perform evalu manufactur order affix ce mark follow procedur refer annex iii draw ec declar conform requir place devic market devic test cover annex ii devic perform evalu manufactur prior draw aforement declar conform fulfil supplementari requir set annex iii point appli procedur manufactur follow procedur refer paragraph devic refer list annex ii intend perform evalu manufactur order affix ce mark follow procedur relat ec declar conform set annex iv full qualiti assur follow procedur relat ec type examin set annex coupl procedur relat ec declar conform set annex vii product qualiti assur devic refer list annex ii intend perform evalu manufactur purpos affix ce mark follow procedur relat ec declar conform set annex iv full qualiti assur procedur relat ec type examin set annex couplet procedur relat ec verif set annex vi ii procedur relat ec declar conform set annex vii product qualiti assur case devic perform evalu manufactur follow procedur refer annex viii draw statement set annex devic made provis affect nation regul relat ethic aspect carri perform evalu studi tissu substanc human origin conform assess procedur devic manufactur involv notifi bodi account result assess verif oper carri accord direct intermedi state manufactur manufactur instruct authoris repres initi procedur provid annex iii vi viii manufactur declar conform technic document refer annex iii viii decis report certif establish notifi bodi make nation author inspect purpos period end year product manufactur manufactur establish commun oblig make aforement document request appli authoris repres conform assess procedur involv intervent notifi bodi manufactur authoris repres appli bodi choic framework task bodi notifi notifi bodi requir duli justifi inform data establish maintain attest conform view chosen procedur decis notifi bodi accord annex iii iv valid maximum year extend applic made time agre contract sign parti period year record correspond relat procedur refer paragraph offici languag member state procedur carri commun languag accept notifi bodi derog paragraph compet author authoris duli justifi request place market put servic territori member state concern individu devic procedur refer paragraph carri interest protect health provis articl appli natur legal person manufactur devic cover direct place market put servic context profession activ articl registr manufactur devic manufactur place devic market notifi compet author member state regist place busi address regist place busi inform relat reagent reagent product calibr control materi term common technolog characterist analyt signific chang thereto includ discontinu place market devic indic case devic cover annex ii devic test data allow identif devic analyt diagnost paramet refer annex part section outcom perform evalu pursuant annex viii certif signific chang thereto includ discontinu place market devic cover annex ii devic test member state request inform data allow identif label instruct devic market put servic territori measur constitut precondit place market put servic devic conform direct manufactur place devic market regist place busi member state design authoris repres authoris repres notifi compet author member state regist place busi particular refer paragraph notif refer paragraph includ devic addit context notif devic notifi bear ce mark product manufactur fact notif purpos articl devic devic continu commun market previou year relev analyt paramet procedur involv analyt technolog continu connect analyt paramet commun market previou year member state measur ensur notif refer paragraph regist immedi databank articl procedur implement articl refer notif concept signific chang adopt accord procedur refer articl transition pend establish european databank access compet author member state data relat devic territori commun manufactur give notif compet author member state concern place market articl vigil procedur member state step ensur inform brought knowledg accord provis direct incid mention involv devic bear ce mark record evalu central malfunct failur deterior characterist perform devic inadequaci label instruct directli indirectli lead led death patient user person deterior state health technic medic reason relat characterist perform devic reason refer subparagraph lead systemat recal devic type manufactur member state requir medic practition medic institut organis extern qualiti assess scheme inform compet author incid refer paragraph step ensur manufactur devic concern authoris repres inform incid carri assess manufactur member state prejudic articl immedi inform commiss member state incid refer paragraph measur includ withdraw contempl context notif refer articl devic notifi bear ce mark product manufactur fact notif compet author notifi time year justifi ground requir manufactur submit report relat experi gain devic subsequ market member state request inform member state detail refer paragraph procedur implement articl adopt accord procedur refer articl articl european databank regulatori data accord direct store european databank access compet author enabl carri task relat direct inform basi databank data relat registr manufactur devic accord articl data relat certif issu modifi supplement suspend withdrawn refus procedur laid annex iii vii data obtain accord vigil procedur defin articl data forward standardis format procedur implement articl adopt accord procedur laid articl articl health monitor measur member state consid relat product group product order ensur protect health safeti ensur public health requir observ pursuant articl treati avail product prohibit restrict made subject requir justifi transit measur inform commiss member state give reason decis commiss consult interest parti member state nation measur justifi adopt commun measur accord procedur refer articl articl amend annex ii derog claus member state consid list devic annex ii amend extend conform devic categori devic establish derog provis articl appli procedur refer articl submit duli substanti request commiss measur measur adopt accord procedur laid articl measur accord paragraph due consider relev inform vigil procedur extern qualiti assess scheme refer articl criteria total relianc result obtain devic result direct impact subsequ medic action ii action basi incorrect result obtain devic prove hazard patient parti public consequ fals posit fals neg result iii involv notifi bodi conduc establish conform devic commiss inform member state measur publish measur offici journal european commun articl notifi bodi member state notifi commiss member state bodi design carri task pertain procedur refer articl specif task bodi design commiss assign identif number bodi hereinaft refer notifi bodi commiss publish list notifi bodi identif number alloc task notifi offici journal european commun ensur list date member state oblig design notifi bodi member state appli criteria set annex ix design bodi bodi meet criteria laid nation standard transpos relev harmonis standard presum meet relev criteria member state appli continu surveil notifi bodi ensur ongo complianc criteria set annex ix member state notifi bodi withdraw restrict notif find bodi longer meet criteria refer annex ix immedi inform member state commiss withdraw notif restrict notifi bodi manufactur authoris repres establish commun lai common accord time limit complet assess verif oper refer annex iii vii notifi bodi inform notifi bodi compet author certif suspend withdrawn request certif issu refus make request addit relev inform notifi bodi find pertin requir direct met longer met manufactur certif issu take account principl proportion suspend withdraw certif issu place restrict complianc requir ensur implement correct measur manufactur case suspens withdraw certif restrict case intervent compet author notifi bodi inform compet author thereof member state inform member state commiss notifi bodi request suppli relev inform document includ budgetari document requir enabl member state verifi complianc annex ix requir articl ce mark devic devic perform evalu consid meet essenti requir refer articl bear ce mark conform market ce mark conform shown annex visibl legibl indel form devic practic instruct ce mark conform sale packag ce mark accompani identif number notifi bodi respons implement procedur set annex iii iv vi vii prohibit affix mark inscript mislead parti regard mean graphic ce mark mark affix devic packag instruct leaflet accompani devic provid visibl legibl ce mark reduc articl wrongli affix ce mark prejudic articl member state establish ce mark wrongli affix manufactur authoris repres oblig end infring condit impos member state complianc continu member state measur restrict prohibit place market product question ensur withdrawn market accord procedur articl provis state paragraph appli ce mark affix accord procedur direct inappropri product cover direct articl decis respect refus restrict decis pursuant direct refus restrict place market make put servic devic withdraw devic market state exact ground base decis notifi delai parti concern time inform remedi nation law forc member state question time limit remedi subject event decis refer paragraph manufactur authoris repres opportun put forward point view advanc consult urgenc measur justifi public health requir articl confidenti prejudic nation law practic medic secreci member state ensur parti involv applic direct bound observ confidenti regard inform obtain carri task affect oblig member state notifi bodi regard mutual inform dissemin warn oblig person concern provid inform crimin law articl cooper member state member state measur ensur compet author charg implement direct cooper convei inform ensur applic complianc direct articl amend direct direct eec indent articl machineri medic direct contact patient replac medic devic direct eec amend articl point replac quot vitro diagnost medic devic quot mean medic devic reagent reagent product calibr control materi kit instrument apparatu equip system combin intend manufactur vitro examin specimen includ blood tissu donat deriv human bodi sole princip purpos provid inform physiolog patholog state congenit abnorm determin safeti compat potenti recipi monitor therapeut measur specimen receptacl consid vitro diagnost medic devic quot specimen receptacl quot devic vacuum type specif intend manufactur primari contain preserv specimen deriv human bodi purpos vitro diagnost examin product gener laboratori vitro diagnost medic devic product view characterist specif intend manufactur vitro diagnost examin point replac quot put servic quot mean stage devic made final user readi commun market time intend purpos point ad quot authoris repres quot mean natur legal person establish commun explicitli design manufactur act address author bodi commun manufactur regard oblig direct articl replac articl place market put servic member state step ensur devic market put servic compli requir laid direct duli suppli properli instal maintain accord intend purpos paragraph ad articl medic devic class iib iii member state request inform data allow identif devic label instruct devic put servic territori articl insert articl european databank regulatori data accord direct store european databas access compet author enabl carri task relat direct inform basi databank data relat registr manufactur devic accord articl data relat certif issu modifi supplement suspend withdrawn refus procedur laid annex ii vii data obtain accord vigil procedur defin articl data forward standardis format procedur implement articl adopt accord procedur laid articl articl health monitor measur member state consid relat product group product order ensur protect health safeti ensur public health requir observ pursuant articl treati avail product prohibit restrict subject requir justifi transit measur inform commiss member state give reason decis commiss consult interest parti member state nation measur justifi adopt commun measur accord procedur refer articl paragraph ad articl notifi bodi inform notifi bodi compet author certif suspend withdrawn request certif issu refus make request addit relev inform notifi bodi find pertin requir direct met longer met manufactur certif issu take account principl proportion suspend withdraw certif issu place restrict complianc requir ensur implement correct measur manufactur case suspens withdraw certif restrict case intervent compet author notifi bodi inform compet author thereof member state inform member state commiss notifi bodi request suppli relev inform document includ budgetari document requir enabl member state verifi complianc annex xi requir paragraph ad articl provis appli ce mark affix accord procedur direct inappropri product cover direct articl subparagraph replac member state accept devic conform rule forc territori decemb market period year adopt direct aforement devic put servic june latest annex ii section annex iii section annex section annex vi section delet annex xi section sentenc insert sentenc presuppos avail suffici scientif staff organis possess experi knowledg suffici assess medic function perform devic notifi regard requir direct set annex articl implement transit provis member state adopt publish law regul administr provis compli direct decemb immedi inform commiss thereof member state appli provis effect june member state adopt provis refer direct accompani refer occas offici public method make refer laid member state member state commun commiss text main provis domest law adopt field govern direct committe refer articl undertak task date entri forc direct member state measur refer articl entri forc direct member state action ensur notifi bodi respons pursuant articl conform assess account relev inform characterist perform devic includ result relev test verif carri pre exist nation law regul administr provis respect devic period year entri forc direct member state accept place market devic conform rule forc territori date direct enter forc addit period year devic put servic articl direct enter forc dai public offici journal european commun articl direct address member state luxembourg octob european parliament presid gil robl council presid hostasch oj oj oj opinion european parliament march oj council common posit march oj decis european parliament june oj council decis octob oj oj direct amend direct eec oj oj oj oj oj direct amend direct eec oj oj direct amend direct ec oj oj oj oj annex essenti requir gener requir devic design manufactur condit purpos intend compromis directli indirectli clinic condit safeti patient safeti health user applic person safeti properti risk accept weigh benefit patient compat high level protect health safeti solut adopt manufactur design construct devic conform safeti principl take account gener acknowledg state art select solut manufactur appli principl order elimin reduc risk inher safe design construct adequ protect measur relat risk elimin inform user residu risk due shortcom protect measur adopt devic design manufactur suitabl purpos refer articl manufactur take account gener acknowledg state art achiev perform term analyt sensit diagnost sensit analyt specif diagnost specif accuraci repeat reproduc includ control relev interfer limit detect state manufactur traceabl valu assign calibr control materi assur refer measur procedur refer materi higher order characterist perform refer section advers affect degre health safeti patient user applic person compromis lifetim devic manufactur devic subject stress occur normal condit lifetim state appli lifetim expect devic kind regard intend purpos anticip devic devic design manufactur pack characterist perform intend advers affect storag transport condit temperatur humid take account instruct inform provid manufactur design manufactur requir chemic physic properti devic design manufactur achiev characterist perform refer section gener requir attent paid possibl impair analyt perform due incompat materi specimen biolog tissu cell bodi fluid micro organ intend devic take account intend purpos devic design manufactur pack reduc risk pose product leakag contamin residu person involv transport storag devic take account intend purpos product infect microbi contamin devic manufactur process design elimin reduc risk infect user person design easi handl reduc contamin leakag devic case specimen receptacl risk contamin specimen manufactur process purpos devic incorpor biolog substanc risk infect reduc select donor substanc valid inactiv conserv test control procedur devic label steril special microbiolog state design manufactur pack pack procedur suitabl ensur remain microbiolog state label market storag transport condit manufactur protect packag damag open devic label steril special microbiolog state process valid method packag system devic refer section product deterior level cleanli manufactur devic sterilis prior reduc risk microbi contamin step reduc microbi contamin select handl raw materi manufactur storag distribut perform devic advers affect contamin devic intend sterilis manufactur appropri control environment condit packag system steril devic product deterior level cleanli stipul devic sterilis prior minimis risk microbi contamin packag system suitabl take account method sterilis manufactur manufactur environment properti devic intend combin devic equip combin includ connect system safe impair perform devic restrict label instruct devic design manufactur reduc risk link conjunct materi substanc gase contact normal condit devic design manufactur remov reduc risk injuri link physic featur aspect volum pressur dimens ergonom featur risk link forese extern influenc magnet field extern electr effect electrostat discharg pressur humid temperatur variat pressur acceler accident penetr substanc devic devic design manufactur provid adequ level intrins immun electromagnet disturb enabl oper intend devic design manufactur reduc risk fire explos normal singl fault condit attent paid devic intend includ exposur associ flammabl substanc substanc combust devic design manufactur facilit manag safe wast dispos measur monitor displai scale includ colour chang visual indic design manufactur line ergonom principl take account intend purpos devic devic instrument apparatu measur function devic instrument apparatu primari analyt measur function design manufactur provid adequ stabil accuraci measur accuraci limit take account intend purpos devic refer measur procedur materi accuraci limit manufactur valu express numer legal unit conform provis council direct eec decemb approxim law member state relat unit measur protect radiat devic design manufactur packag exposur user person emit radiat minimis devic intend emit potenti hazard visibl invis radiat design manufactur ensur characterist quantiti radiat emit control adjust fit visual displai audibl warn emiss oper instruct devic emit radiat give detail inform natur emit radiat mean protect user wai avoid misus elimin risk inher instal requir medic devic connect equip energi sourc devic incorpor electron programm system includ softwar design ensur repeat reliabl perform system intend devic design manufactur minimis risk creat electromagnet perturb impair oper devic equip usual environ devic design manufactur avoid risk accident electr shock normal singl fault condit provid devic instal maintain correctli protect mechan thermal risk devic design manufactur protect user mechan risk devic suffici stabl foreseen oper condit suitabl withstand stress inher foreseen work environ retain resist expect life devic subject inspect mainten requir manufactur risk due presenc move part risk due break detach leakag substanc protect mean incorpor guard mean includ devic provid protect move part secur interfer access normal oper devic restrict routin mainten devic intend manufactur devic design manufactur reduc lowest level risk aris vibrat gener devic take account technic progress mean limit vibrat sourc vibrat part perform devic design manufactur reduc risk aris nois emit take account technic progress mean reduc nois sourc nois emit part perform termin connector electr ga hydraul pneumat energi suppli user handl design manufactur minimis risk access part devic exclud part area intend suppli heat reach temperatur surround attain potenti danger temperatur normal requir devic test devic test design manufactur perform appropri intend purpos take account skill mean user influenc result variat anticip user techniqu environ inform instruct provid manufactur easili understood appli user devic test design manufactur ensur devic easi intend lai user stage procedur reduc practic risk user error handl devic interpret result devic test includ user control procedur user verifi time product perform intend inform suppli manufactur devic accompani inform need safe properli take account train knowledg potenti user identifi manufactur inform compris data label instruct practic inform need devic safe properli set devic sale packag individu full label unit practic inform set packag instruct suppli devic instruct accompani includ packag devic duli justifi except case instruct need devic properli safe inform suppli form symbol symbol identif colour conform harmonis standard area standard exist symbol colour document suppli devic case devic prepar consid danger take account natur quantiti constitu form present relev danger symbol label requir direct eec direct eec appli insuffici space put inform devic label relev danger symbol put label inform requir direct instruct provis aforement direct safeti data sheet appli relev inform made instruct label bear particular form symbol trade address manufactur devic import commun view distribut commun label outer packag instruct addit address authoris repres manufactur detail strictli user uniqu identifi devic content packag word steril statement indic special microbiolog state state cleanli batch code preced word lot serial number indic date devic part safeti degrad perform express year month relev dai order case devic perform evalu word perform evalu statement indic vitro devic storag handl condit applic oper instruct warn precaut devic intend test fact state intend purpos devic obviou user manufactur state intend purpos instruct label reason practic devic separ compon identifi term batch action detect potenti risk pose devic detach compon instruct particular detail refer section except point composit reagent product natur amount concentr activ ingredi reagent kit statement devic ingredi influenc measur storag condit shelf life open primari contain storag condit stabil work reagent perform refer section part indic special equip requir includ inform identif special equip proper type specimen special condit collect pre treatment storag condit instruct prepar patient detail descript procedur devic measur procedur devic includ principl method specif analyt perform characterist sensit specif accuraci repeat reproduc limit detect measur rang includ inform need control relev interfer limit method inform refer measur procedur materi user detail procedur handl need devic reconstitut incub dilut instrument check indic train requir mathemat approach calcul analyt result made measur event analyt perform devic inform user intern qualiti control includ specif valid procedur traceabl calibr devic refer interv quantiti determin includ descript refer popul devic combin instal connect medic devic equip order oper requir intend purpos suffici detail characterist identifi correct devic equip order obtain safe proper combin inform need verifi devic properli instal oper correctli safe detail natur frequenc mainten calibr need ensur devic oper properli safe inform safe wast dispos detail treatment handl need devic sterilis final assembl instruct event damag protect packag detail method resterilis decontamin devic reusabl inform process reus includ clean disinfect packag resterilis decontamin restrict number reus precaut exposur forese environment condit magnet field extern electr influenc electrostat discharg pressur variat pressur acceler thermal ignit sourc precaut special unusu risk relat dispos devic includ special protect measur devic includ substanc human anim origin attent drawn potenti infecti natur specif devic test result express present readili understood lai person inform provid advic user action case posit neg indetermin result possibl fals posit fals neg result specif particular omit provid inform suppli manufactur suffici enabl user devic understand result produc devic inform provid includ statement direct user decis medic relev consult medic practition inform devic test monitor exist diseas patient adapt treatment receiv train date issu latest revis instruct oj direct amend direct eec oj council direct eec june approxim law regul administr provis relat classif packag label danger substanc oj direct amend commiss direct ec oj council direct eec june approxim law regul administr provis member state relat classif packag label danger prepar oj direct amend commiss direct ec oj annex ii list devic refer articl 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 list reagent reagent product includ relat calibr control materi determin blood group anti duffi anti kidd reagent reagent product includ relat calibr control materi determin irregular anti erythrocyt antibodi reagent reagent product includ relat calibr control materi detect quantif human sampl congenit infect rubella toxoplasmosi reagent reagent product includ relat calibr control materi diagnos hereditari diseas phenylketonuria reagent reagent product includ relat calibr control materi determin human infect cytomegaloviru chlamydia reagent reagent product includ relat calibr control materi determin hla tissu group dr reagent reagent product includ relat calibr control materi determin tumor marker psa reagent reagent product includ relat calibr control materi softwar design specif evalu risk trisomi devic diagnosi includ relat calibr control materi devic measur blood sugar annex iii ec declar conform ec declar conform procedur manufactur authoris repres fulfil oblig impos section addition case devic test oblig impos section ensur declar product concern meet provis direct appli manufactur affix ce mark accord articl manufactur prepar technic document section ensur manufactur process principl qualiti assur set section technic document assess conform product requir direct includ gener descript product includ variant plan document qualiti system design inform includ determin characterist basic materi characterist limit perform devic method manufactur case instrument design draw diagram compon assembl circuit case devic tissu human origin substanc deriv tissu inform origin materi condit collect descript explan understand abovement characterist draw diagram oper product result risk analysi list standard refer articl appli full part descript solut adopt meet essenti requir direct standard refer articl appli full case steril product product special microbiolog state state cleanli descript procedur result design calcul inspect carri devic combin devic order oper intend proof provid conform essenti requir combin devic characterist manufactur test report adequ perform evalu data show perform claim manufactur support refer measur system inform refer method refer materi refer valu accuraci measur unit data origin studi clinic environ result relev biograph refer label instruct result stabil studi manufactur measur ensur manufactur process principl qualiti assur product manufactur system address organis structur respons manufactur process systemat qualiti control product mean monitor perform qualiti system manufactur institut date systemat procedur review experi gain devic post product phase implement mean appli correct action take account natur risk relat product notifi compet author incid immedi learn malfunct failur deterior characterist perform devic inadequaci label instruct directli indirectli lead led death patient user person deterior state health ii technic medic reason connect characterist perform devic reason refer subparagraph lead systemat recal devic type manufactur devic test manufactur lodg applic examin design notifi bodi applic enabl design devic understood enabl conform design relat requir direct assess includ test report includ result studi carri lai person data show handl suitabl devic view intend purpos test inform provid devic label instruct notifi bodi examin applic design conform relev provis direct issu applic ec design examin certif notifi bodi requir applic complet test proof assess conform design relat requir direct certif conclus examin condit valid data need identif approv design descript intend purpos product applic inform notifi bodi issu ec design examin certif signific chang made approv design approv design receiv approv notifi bodi issu ec design examin certif affect conform essenti requir direct condit prescrib product addit approv form supplement ec design examin certif annex iv ec declar conform full qualiti assur system manufactur ensur applic qualiti system approv design manufactur final inspect devic concern section subject audit laid section surveil section addit manufactur follow devic cover annex ii list procedur laid section declar conform procedur manufactur fulfil oblig impos section ensur declar devic concern meet provis direct appli manufactur affix ce mark accord articl draw declar conform cover devic concern qualiti system manufactur lodg applic assess qualiti system notifi bodi applic includ address manufactur addit manufactur site cover qualiti system adequ inform devic devic categori cover procedur written declar applic lodg notifi bodi devic relat qualiti system document qualiti system undertak manufactur fulfil oblig impos qualiti system approv undertak manufactur approv qualiti system adequ efficaci undertak manufactur institut date systemat procedur review experi gain devic post product phase implement mean appli correct action notif refer annex iii section applic qualiti system ensur devic conform provis direct appli stage design final inspect element requir provis adopt manufactur qualiti system document systemat orderli manner form written polici procedur qualiti programm qualiti plan qualiti manual qualiti record includ adequ descript manufactur qualiti object organis busi organis structur respons manageri staff organis author qualiti design manufactur devic concern method monitor effici oper qualiti system abil achiev desir qualiti design product includ control devic fail conform procedur monitor verifi design devic gener descript devic includ variant plan document refer annex iii section indent case devic test inform refer annex iii section techniqu control verifi design process systemat measur devic design inspect qualiti assur techniqu manufactur stage process procedur sterilis procedur relat purchas product identif procedur drawn date draw specif relev document stage manufactur test trial carri manufactur frequenc place test equip trace back calibr manufactur carri requir control test latest state art control test cover manufactur process includ characteris raw materi individu devic batch devic manufactur test devic cover annex ii list manufactur account recent inform biolog complex variabl specimen test vitro devic concern notifi bodi audit qualiti system determin meet requir refer section presum qualiti system implement relev harmonis standard conform requir assess team experi assess technolog concern assess procedur includ inspect manufactur premis duli substanti case premis manufactur supplier subcontractor inspect manufactur process decis notifi manufactur conclus inspect reason assess manufactur inform notifi bodi approv qualiti system plan substanti qualiti system product rang cover notifi bodi assess propos verifi qualiti system meet requir refer section notifi manufactur decis decis conclus inspect reason assess examin design product devic cover annex ii list addit oblig impos section manufactur lodg notifi bodi applic examin design dossier relat devic plan manufactur fall categori refer section applic describ design manufactur perform devic question includ document need assess devic conform requir direct refer section notifi bodi examin applic devic conform relev provis direct issu applic ec design examin certif notifi bodi requir applic complet test proof assess conform requir direct certif conclus examin condit valid data need identif approv design descript intend purpos devic approv design receiv approv notifi bodi issu ec design examin certif affect conform essenti requir direct condit prescrib devic applic inform notifi bodi issu ec design examin certif made approv design addit approv form supplement ec design examin certif manufactur inform notifi bodi delai obtain inform pathogen marker infect test consequ biolog complex variabl connect manufactur inform notifi bodi chang affect perform vitro diagnost medic devic concern surveil aim surveil ensur manufactur duli fulfil oblig impos approv qualiti system manufactur authoris notifi bodi carri inspect suppli relev inform document qualiti system data stipul part qualiti system relat design result analys calcul test data stipul part qualiti system relat manufactur inspect report test data calibr data qualif report personnel concern notifi bodi period carri inspect assess make manufactur appli approv qualiti system suppli manufactur assess report addit notifi bodi pai unannounc visit manufactur time visit notifi bodi carri test order check qualiti system work properli provid manufactur inspect report test carri test report verif manufactur product cover annex ii list case devic cover annex ii list manufactur forward notifi bodi delai conclus control test relev report test carri manufactur devic batch devic manufactur make sampl manufactur devic batch devic notifi bodi accord pre agre condit modal manufactur place devic market notifi bodi commun manufactur agre time frame dai recept sampl decis includ condit valid deliv certif annex ec type examin ec type examin part procedur notifi bodi ascertain certifi repres sampl product envisag fulfil relev provis direct applic ec type examin lodg manufactur authoris repres notifi bodi applic includ address manufactur address authoris repres applic lodg repres document section need assess conform repres sampl product question hereinaft refer type requir direct applic make type notifi bodi notifi bodi request sampl written declar applic lodg notifi bodi type document understand design manufactur perform devic document item gener descript type includ variant plan document refer annex iii section indent case devic test inform refer annex iii section notifi bodi examin assess document verifi type manufactur conform document record item design conform applic provis standard refer articl item design basi relev provis abovement standard perform perform examin test verifi solut adopt manufactur meet essenti requir direct standard refer articl appli devic combin devic order oper intend proof provid conform essenti requir combin devic characterist manufactur carri examin test verifi manufactur chosen appli relev standard appli agre applic place examin test carri type conform provis direct notifi bodi issu applic ec type examin certif certif address manufactur conclus examin condit valid data need identif type approv relev part document annex certif copi notifi bodi manufactur inform notifi bodi delai obtain inform pathogen marker infect test consequ biolog complex variabl connect manufactur inform notifi bodi chang affect perform vitro devic concern approv devic receiv approv notifi bodi issu ec type examin certif affect conform essenti requir direct condit prescrib devic applic inform notifi bodi issu ec type examin certif chang made approv devic approv form supplement initi ec type examin certif administr provis notifi bodi obtain copi ec type examin certif supplement thereto annex certif notifi bodi reason applic manufactur inform annex vi ec verif ec verif procedur manufactur authoris repres ensur declar product subject procedur set section conform type ec type examin certif meet requir direct appli manufactur measur ensur manufactur process produc product conform type ec type examin certif requir direct appli start manufactur manufactur prepar document defin manufactur process sterilis suitabl start materi defin test procedur state art routin pre establish provis implement ensur homogen product conform product type ec type examin certif requir direct appli extent aspect final test section adequ process test monitor control method establish manufactur approv notifi bodi provis annex iv section appli relat abovement approv procedur manufactur undertak institut date systemat procedur review experi gain devic post product phase implement mean appli correct notif action refer annex iii section notifi bodi carri examin test take account section order verifi conform product requir direct examin test product section examin test product statist basi section manufactur decid carri statist verif section notifi bodi decid statist procedur lot lot inspect isol lot inspect appli decis consult manufactur conduct examin test statist basi examin test carri random basi provid procedur conjunct measur accord section ensur equival level conform verif examin test product product examin individu test defin relev standard refer articl equival test carri order verifi conform product ec type type examin certif requir direct appli notifi bodi affix affix identif number approv product draw written certif conform relat test carri statist verif manufactur present manufactur product form homogen batch random sampl batch product make sampl examin test defin relev standard refer articl equival test carri verifi conform product type ec type examin certif requir direct appli order determin accept reject batch statist control product base attribut variabl entail sampl scheme oper characterist ensur high level safeti perform state art sampl scheme establish harmonis standard refer articl take account specif natur product categori question batch accept notifi bodi affix affix identif number product draw written certif conform relat test carri product batch put market sampl fail conform batch reject compet notifi bodi measur prevent batch market event frequent reject batch notifi bodi suspend statist verif manufactur respons notifi bodi affix notifi bodi identif number manufactur process annex vii ec declar conform product qualiti assur manufactur ensur applic qualiti system approv manufactur devic concern carri final inspect section subject surveil refer section declar conform part procedur manufactur fulfil oblig impos section ensur declar product concern conform type ec type examin certif meet provis direct appli manufactur affix ce mark accord articl draw declar conform cover devic concern qualiti system manufactur lodg applic assess qualiti system notifi bodi applic includ document undertak refer annex iv section technic document type approv copi ec type examin certif applic qualiti system ensur devic conform type ec type examin certif element requir provis adopt manufactur qualiti system document systemat orderli manner form written polici statement procedur qualiti system document permit uniform interpret qualiti polici procedur qualiti programm plan manual record includ adequ descript manufactur qualiti object organis busi organis structur respons manageri staff organis author qualiti manufactur devic concern method monitor effici oper qualiti system abil achiev desir qualiti product includ control devic fail conform inspect qualiti assur techniqu manufactur stage process procedur sterilis procedur relat purchas product identif procedur drawn date draw specif relev document stage manufactur test trial carri manufactur frequenc place test equip trace back calibr notifi bodi audit qualiti system determin meet requir refer section presum qualiti system implement relev harmonis standard conform requir assess team past experi assess technolog concern assess procedur includ inspect manufactur premis duli substanti case premis manufactur supplier subcontractor inspect manufactur process decis notifi manufactur conclus inspect reason assess manufactur inform notifi bodi approv qualiti system plan substanti qualiti system notifi bodi assess propos verifi qualiti system meet requir refer section notifi manufactur decis decis conclus inspect reason assess surveil provis annex iv section appli verif manufactur product cover annex ii list case devic cover annex ii list manufactur forward notifi bodi delai conclus control test relev report test carri manufactur devic batch devic manufactur make sampl manufactur devic batch devic notifi bodi accord pre agre condit modal manufactur place devic market notifi bodi commun manufactur agre time frame dai recept sampl decis includ condit valid deliv certif annex viii statement procedur devic perform evalu devic perform evalu manufactur authoris repres draw statement inform stipul section ensur relev provis direct met statement inform data allow identif devic question evalu plan state purpos scientif technic medic ground scope evalu number devic concern list laboratori institut take part evalu studi start date schedul durat evalu case devic test locat number lai person involv statement devic question conform requir direct aspect cover evalu specif itemis statement precaut protect health safeti patient user person manufactur undertak compet nation author document allow understand design manufactur perform product includ expect perform assess conform requir direct document period end year end perform evalu manufactur measur manufactur process ensur product manufactur conform document mention paragraph provis articl appli devic intend perform evalu annex ix criteria design notifi bodi notifi bodi director assess verif staff design manufactur supplier instal user devic inspect authoris repres person directli involv design construct market mainten devic repres parti engag activ preclud possibl exchang technic inform manufactur bodi notifi bodi staff carri assess verif oper highest degre profession integr requisit compet field medic devic free pressur induc financi influenc judgment result inspect person group person interest result verif notifi bodi subcontract specif task connect establish verif fact ensur subcontractor meet provis direct notifi bodi dispos nation author relev document assess subcontractor qualif work carri subcontractor direct notifi bodi carri task assign bodi annex iii vii notifi task carri bodi respons staff possess facil need perform properli technic administr task entail assess verif includ avail suffici scientif staff organis possess adequ experi knowledg assess biolog medic function perform devic notifi relat requir direct annex requir notifi bodi access equip verif requir inspect staff sound vocat train cover assess verif oper bodi design satisfactori knowledg rule inspect carri adequ experi inspect abil requir draw certif record report demonstr inspect carri imparti inspect staff guarante remuner depend number inspect carri result inspect bodi civil liabil insur liabil assum state domest legisl member state carri inspect directli staff inspect bodi bound observ profession secreci regard inform gain duti vi vi compet administr author state activ carri direct provis nation law put effect annex ce mark conform ce conform mark consist initi ce take form gt refer graphic gt mark reduc enlarg proport graduat draw respect compon ce mark substanti vertic dimens mm minimum dimens waiv small scale devic