council direct eec june medic devic council european commun regard treati establish european econom commun articl thereof regard propos commiss cooper european parliament regard opinion econom social committe measur adopt context 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 medic devic certif inspect procedur devic differ member state dispar constitut barrier trade commun nation provis safeti health protect patient user person regard medic devic harmon order guarante free movement devic intern market harmon provis distinguish measur adopt member state manag fund public health sick insur scheme relat directli indirectli devic provis affect abil member state implement abovement measur provid commun law compli medic devic provid patient user parti high level protect attain perform level attribut manufactur mainten improv level protect attain member state essenti object direct medic devic intend administ medicin product mean council direct eec januari approxim provis laid law regul administr action relat proprietari medicin product case place market medic devic gener rule govern present direct place market medicin product govern direct eec devic market devic medicin product form singl integr unit intend exclus combin reusabl singl unit product govern direct eec distinct drawn abovement devic medic devic incorpor inter alia substanc separ consid medicin substanc mean direct eec case substanc incorpor medic devic liabl act bodi action ancillari devic place devic market govern direct context safeti qualiti us substanc verifi analog method council direct eec approxim law member state relat analyt pharmaco toxicolog clinic standard protocol respect test proprietari medicin product essenti requir requir set annex direct includ refer minim reduc risk interpret appli account technolog practic exist time design technic econom consider compat high level protect health safeti accord principl set council resolut approach technic harmon standard rule design manufactur medic devic confin provis requir meet essenti requir essenti requir replac nation provis essenti requir appli discret account technolog level exist time design technic econom consider compat high level protect health safeti council direct eec june approxim law member state relat activ implant medic devic case applic approach field medic devic interest uniform commun rule applic medic devic direct base larg provis direct eec reason direct eec amend insert gener provis laid direct electromagnet compat aspect form integr part safeti medic devic direct specif rule subject regard council direct eec approxim law member state relat electromagnet compat direct includ requir design manufactur devic emit ioniz radiat direct affect author requir council direct euratom juli amend direct lai basic safeti standard health protect gener public worker danger ioniz radiat applic council direct euratom septemb lai basic measur radiat protect person undergo medic examin treatment council direct eec june introduct measur encourag improv safeti health worker work specif direct subject continu appli order demonstr conform essenti requir enabl conform verifi desir harmon european standard protect risk design manufactur packag medic devic harmon european standard drawn privat law bodi retain statu mandatori text end european committe standard cen european committe electrotechn standard cenelec recogn compet bodi adopt harmon standard accord gener guidelin cooper commiss bodi sign novemb purpos direct harmon standard technic specif european standard harmon document adopt mandat commiss bodi accord council direct eec march lai procedur provis inform field technic standard regul pursuant abovement gener guidelin regard amend harmon standard commiss assist committe set pursuant direct eec measur defin line procedur laid council decis eec specif field exist form european pharmacopoeia monograph incorpor framework direct european pharmacopoeia monograph consid equal abovement harmon standard decis eec decemb modul phase conform assess procedur intend technic harmon direct council laid harmon conform assess procedur applic modul medic devic enabl respons manufactur notifi bodi determin conform assess procedur basi type devic concern detail ad modul justifi natur verif requir medic devic essenti purpos conform assess procedur group devic product class classif rule base vulner human bodi take account potenti risk technic design manufactur devic conform assess procedur class devic carri gener rule sole respons manufactur view low level vulner product class iia devic intervent notifi bodi compulsori product stage devic fall class iib iii constitut high risk potenti inspect notifi bodi requir regard design manufactur devic class iii set critic devic explicit prior author regard conform requir market case conform devic assess respons manufactur compet author emerg contact person respons place devic market establish commun manufactur person establish commun design manufactur purpos medic devic gener rule bear ce mark conform provis direct enabl move freeli commun put servic accord intend purpos fight aid light conclus council adopt futur activ aid prevent control commun level medic devic protect hiv viru afford high level protect design manufactur product verifi notifi bodi classif rule gener enabl medic devic appropri classifi view divers natur devic technolog progress field step includ implement power confer commiss decis regard proper classif reclassif devic adjust classif rule issu close connect protect health decis procedur iiia provid direct eec confirm complic essenti requir clinic investig carri respons manufactur purpos carri clinic investig mean protect public health public order protect health control made effect mean medic devic vigil system integr commun level direct cover medic devic refer council direct eec juli approxim law member state clinic mercuri glass maximum read thermomet abovement direct repeal reason council direct eec septemb approxim law member state relat electro medic equip human veterinari medicin amend adopt direct articl definit scope direct appli medic devic accessori purpos direct accessori treat medic devic 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 accessori mean articl whilst devic intend specif manufactur devic enabl accord devic intend manufactur devic devic vitro diagnosi mean devic reagent reagent product kit instrument equip system combin intend manufactur vitro examin sampl deriv human bodi view provid inform physiolog state state health diseas congenit abnorm thereof custom made devic mean devic specif made accord duli qualifi medic practition written prescript respons specif design characterist intend sole patient abovement prescript made person author virtu profession qualif mass produc devic adapt meet specif requir medic practition profession user consid custom made devic devic intend clinic investig mean devic intend duli qualifi medic practition conduct investig refer section annex adequ human clinic environ purpos conduct clinic investig person virtu profession qualif author carri investig accept equival duli qualifi medic practition 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 intend purpos mean devic intend data suppli manufactur label instruct promot materi place market mean make return payment free charg devic devic intend clinic investig view distribut commun market fulli refurbish put servic mean stage devic readi commun market time intend purpos devic intend administ medicin product mean articl direct eec devic govern present direct prejudic provis direct eec regard medicin product devic market devic medicin product form singl integr product intend exclus combin reusabl singl product govern direct eec relev essenti requir annex present direct appli safeti perform relat devic featur concern devic incorpor integr part substanc separ consid medicin product mean articl direct eec liabl act bodi action ancillari devic devic assess author accord direct direct appli vitro diagnost devic activ implant devic cover direct eec medicin product cover direct eec cosmet product cover direct eec human blood human blood product human plasma blood cell human origin devic incorpor time place market blood product plasma cell transplant tissu cell human origin product incorpor deriv tissu cell human origin transplant tissu cell anim origin devic manufactur util anim tissu render viabl viabl product deriv anim tissu direct appli person protect equip cover direct eec decid product fall direct present direct account princip intend purpos product direct specif direct mean articl direct eec direct affect applic direct euratom direct euratom articl place market put servic member state step ensur devic market put servic compromis safeti health patient user applic person properli instal maintain accord intend purpos articl essenti requir devic meet essenti requir set annex appli take account intend purpos devic concern articl free movement devic intend special purpos member state creat obstacl place market put servic territori devic bear ce mark provid articl subject assess conform accord provis articl member state creat obstacl devic intend clinic investig made medic practition author person purpos meet condit laid articl annex viii custom made devic market put servic meet condit laid articl combin annex viii class iia iib iii devic accompani statement refer annex viii devic bear ce mark trade fair exhibit demonstr member state creat obstacl show devic conform direct provid visibl sign devic market put servic made compli member state requir inform made user patient accord annex point nation languag commun languag devic reach final user profession 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 adopt pursuant harmon standard refer publish offici journal european commun member state publish refer nation standard purpos direct refer harmon standard includ monograph european pharmacopoeia notabl surgic sutur interact medicin product materi devic medicin product refer publish offici journal european commun member state commiss consid harmon standard meet essenti requir refer articl measur member state regard standard public refer paragraph articl adopt procedur defin articl articl committe standard technic regul commiss assist committe set articl direct eec 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 examin question connect implement direct articl safeguard claus member state ascertain devic refer articl indent correctli instal maintain intend purpos compromis health safeti patient user applic person 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 unjustifi immedi inform member state initi manufactur author repres establish commun 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 classif devic divid class iia iib iii classif carri accord annex ix event disput manufactur notifi bodi concern result applic classif rule matter refer decis compet author notifi bodi subject classif rule set annex ix adapt accord procedur refer articl light technic progress inform inform system provid articl articl inform incid occur place devic market member state step ensur inform brought knowledg accord provis direct incid mention involv class iia iib iii devic record evalu central malfunct deterior characterist perform devic inadequaci label instruct lead led death patient user 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 inform compet author incid refer paragraph step ensur manufactur devic concern author repres establish commun inform incid carri assess manufactur member state prejudic articl immedi inform commiss member state incid refer paragraph relev measur contempl articl conform assess procedur case devic fall class iii devic custom made intend clinic investig manufactur order affix ce mark follow procedur relat ec declar conform set annex ii full qualiti assur follow procedur relat ec type examin set annex iii coupl procedur relat ec verif set annex iv ii procedur relat ec declar conform set annex product qualiti assur case devic fall class iia devic custom made intend clinic investig manufactur order affix ce mark follow procedur relat ec declar conform set annex vii coupl procedur relat ec verif set annex iv procedur relat ec declar conform set annex product qualiti assur procedur relat ec declar conform set annex vi product qualiti assur appli procedur manufactur follow procedur refer paragraph case devic fall class iib devic custom made intend clinic investig manufactur order affix ce mark follow procedur relat ec declar conform set annex ii full qualiti assur case point annex ii applic follow procedur relat ec type examin set annex iii coupl procedur relat ec verif set annex iv ii procedur relat ec declar conform set annex product qualiti assur iii procedur relat ec declar conform set annex vi product qualiti assur commiss year date implement direct submit report council oper provis refer articl articl respect class class iia devic oper provis refer annex ii section subparagraph annex iii section subparagraph direct accompani propos case devic fall class devic custom made intend clinic investig manufactur order affix ce mark follow procedur refer annex vii draw ec declar conform requir place devic market case custom made devic manufactur follow procedur refer annex viii draw statement set annex place devic market member state requir manufactur submit compet author list devic put servic territori conform assess procedur devic manufactur notifi bodi account result assess verif oper carri accord direct intermedi stage manufactur manufactur instruct author repres establish commun initi procedur provid annex iii iv vii viii conform assess procedur involv intervent notifi bodi manufactur author repres establish commun 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 ii iii 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 author duli justifi request place market put servic territori member state concern individu devic procedur refer paragraph carri interest protect health articl procedur system procedur pack derog articl articl appli system procedur pack natur legal person put devic bear ce mark intend purpos limit manufactur order place market system procedur pack draw declar state verifi mutual compat devic accord manufactur instruct carri oper accord instruct packag system procedur pack suppli relev inform user incorpor relev instruct manufactur activ subject method intern control inspect condit met case system procedur pack incorpor devic bear ce mark chosen combin devic compat view origin intend system procedur pack treat devic subject relev procedur pursuant articl natur legal person steril purpos place market system procedur pack refer paragraph ce mark medic devic design manufactur steril choic follow procedur refer annex iv vi applic abovement annex intervent notifi bodi limit aspect procedur relat obtain steril person draw declar state steril carri accord manufactur instruct product refer paragraph bear addit ce mark accompani inform refer point annex includ inform suppli manufactur devic put declar refer paragraph dispos compet author period year articl decis regard classif derog claus member state consid applic classif rule set annex ix requir decis regard classif devic categori devic devic famili devic classifi derog provis annex ix class conform devic famili devic establish derog provis articl appli sole procedur chosen refer articl submit duli substanti request commiss measur measur adopt accord procedur refer articl commiss inform member state measur publish relev part measur offici journal european commun articl registr person respons place devic market manufactur place devic market accord procedur refer articl natur legal person engag activ refer articl inform compet author member state regist place busi address regist place busi descript devic concern manufactur place devic refer paragraph market regist place busi member state design person respons market establish commun person inform compet author member state regist place busi address regist place busi categori devic concern member state request inform member state commiss detail refer paragraph articl clinic investig case devic intend clinic investig manufactur author repres establish commun follow procedur refer annex viii notifi compet author member state investig conduct case devic fall class iii implant long term invas devic fall class iia iib manufactur commenc relev clinic investig end period dai notif compet author notifi period decis contrari base consider public health public polici member state author manufactur commenc relev clinic investig expiri period dai relev ethic committe issu favour opinion programm investig question case devic refer paragraph member state author manufactur commenc clinic investig immedi date notif provid ethic committe concern deliv favour opinion regard investig plan author refer paragraph subparagraph paragraph made subject author compet author clinic investig conduct accord provis annex provis annex adjust accord procedur laid articl member state step ensur public health public polici manufactur author repres establish commun report refer point annex dispos compet author provis paragraph appli clinic investig conduct devic author accord articl bear ce mark aim investig devic purpos refer relev conform assess procedur relev provis annex remain applic 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 appli criteria set annex xi design bodi bodi meet criteria laid nation standard transpos relev harmon standard presum meet relev criteria member state notifi bodi withdraw notif find bodi longer meet criteria refer paragraph immedi inform member state commiss thereof notifi bodi manufactur author repres establish commun lai common accord time limit complet assess verif oper refer annex ii vi articl ce mark devic devic custom made intend clinic investig consid meet essenti requir refer articl bear ce mark conform market ce mark conform shown annex xii visibl legibl indel form devic steril pack practic instruct applic ce mark sale packag accompani identif number notifi bodi respons implement procedur set annex ii iv vi 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 affix unduli manufactur author repres establish commun oblig end infring condit impos member state complianc continu member state measur restrict prohibit place market product question ensur withdrawn market accord procedur articl articl decis respect refus restrict decis pursuant direct refus restrict place market put servic devic carri clinic investig 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 author repres establish commun opportun put forward viewpoint advanc consult urgenc measur articl confidenti prejudic exist nation provis practic medic secret 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 repeal amend direct direct eec repeal effect januari titl articl direct eec human delet articl direct eec subparagraph ad paragraph applianc time medic devic mean direct eec satisfi essenti requir laid devic devic deem conform requir direct oj direct eec amend articl subparagraph ad quot place market quot mean make return payment free charg devic devic intend clinic investig view distribut commun market fulli refurbish quot manufactur quot 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 articl paragraph ad conform assess procedur devic manufactur notifi bodi account result assess verif oper carri accord direct intermedi stage manufactur conform assess procedur involv intervent notifi bodi manufactur author repres establish commun 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 ii iii valid maximum year extend applic made time agre contract sign parti period year derog paragraph compet author author duli justifi request place market put servic territori member state concern individu devic procedur refer paragraph carri interest protect health articl insert articl articl member state consid conform devic famili devic establish derog provis articl appli sole procedur chosen refer articl submit duli substanti request commiss measur measur adopt accord procedur refer articl direct eec commiss inform member state measur publish relev part measur offici journal european commun oj articl amend subparagraph ad paragraph member state author manufactur start clinic investig question expiri dai period provid ethic committe concern deliv favour opinion respect investig programm question paragraph insert author refer subparagraph paragraph subject approv compet author ad articl event decis refer previou paragraph manufactur author repres establish commun opportun put forward viewpoint advanc consult urgenc measur articl implement transit provis member state adopt publish law regul administr provis compli direct juli immedi inform commiss thereof stand committe refer articl assum task date notif direct member state measur refer articl notif direct member state adopt provis refer direct accompani refer time offici public procedur refer adopt member state member state appli provis effect januari member state commun commiss text provis nation law adopt field cover 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 member state accept place market put servic devic conform rule forc territori decemb period year adopt direct case devic subject eec pattern approv accord direct eec member state accept market put servic period june articl direct address member state luxembourg june council presid troejborg oj oj oj oj oj oj direct amend direct eec oj oj direct amend direct eec oj oj oj oj direct amend direct eec oj oj direct amend direct euratom oj oj oj oj direct amend commiss decis eec oj oj oj oj oj direct amend direct eec oj oj direct amend act access spain portug oj direct amend commiss direct eec oj direct notifi member state june annex essenti requir gener requir devic design manufactur condit purpos intend compromis clinic condit safeti patient safeti health user applic person provid risk constitut accept risk 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 includ alarm relat risk elimin inform user residu risk due shortcom protect measur adopt devic achiev perform intend manufactur design manufactur packag suitabl function refer articl manufactur characterist perform refer section advers affect degre clinic condit safeti patient applic person compromis lifetim devic manufactur devic subject stress occur normal condit devic design manufactur pack characterist perform intend advers affect transport storag take account instruct inform provid manufactur undesir side effect constitut accept risk weigh perform intend ii requir design construct chemic physic biolog properti devic design manufactur guarante characterist perform refer section gener requir attent paid choic materi toxic flammabl compat materi biolog tissu cell bodi fluid take account intend purpos devic devic design manufactur pack minim risk pose contamin residu person involv transport storag devic patient take account intend purpos product attent paid tissu expos durat frequenc exposur devic design manufactur safe materi substanc gase enter contact normal routin procedur devic intend administ medicin product design manufactur compat medicin product concern provis restrict govern product perform maintain accord intend devic incorpor integr part substanc separ consid medicin product defin articl direct eec liabl act bodi action ancillari devic safeti qualiti us substanc verifi take account intend purpos devic analog method direct eec devic design manufactur reduc minimum risk pose substanc leak devic devic design manufactur reduc risk pose unintent ingress substanc devic take account devic natur environ intend infect microbi contamin devic manufactur process design elimin reduc risk infect patient user parti design easi handl minim contamin devic patient vice versa tissu anim origin origin anim subject veterinari control surveil adapt intend tissu notifi bodi retain inform geograph origin anim process preserv test handl tissu cell substanc anim origin carri provid optim secur safeti regard virus transfer agent address implement valid method elimin viral inactiv manufactur process devic deliv steril state design manufactur pack reusabl pack procedur ensur steril market remain steril storag transport condit laid protect packag damag open devic deliv steril state manufactur steril valid method devic intend steril manufactur appropri control environment condit packag system steril devic product deterior level cleanli stipul devic steril prior minim risk microbi contamin packag system suitabl take account method steril manufactur packag label devic distinguish ident similar product sold steril steril condit construct environment properti devic intend combin devic equip combin includ connect system safe impair perform devic restrict label instruct devic design manufactur remov minim risk injuri connect physic featur includ volum pressur ratio dimension ergonom featur risk connect forese environment condit magnet field extern electr influenc electrostat discharg pressur temperatur variat pressur acceler risk reciproc interfer devic investig treatment risk aris mainten calibr implant ag materi loss accuraci measur control mechan devic design manufactur minim risk fire explos normal singl fault condit attent paid devic intend includ exposur flammabl substanc substanc combust devic measur function devic measur function design manufactur provid suffici accuraci stabil limit accuraci take account intend purpos devic limit accuraci manufactur measur monitor displai scale design line ergonom principl take account intend purpos devic measur made devic measur function express legal unit conform provis council direct eec protect radiat gener devic design manufactur exposur patient user person radiat reduc compat intend purpos whilst restrict applic level therapeut diagnost purpos intend radiat devic design emit hazard level radiat specif medic purpos benefit consid outweigh risk inher emiss user control emiss devic design manufactur ensur reproduc toler relev variabl paramet devic intend emit potenti hazard visibl invis radiat fit practic visual displai audibl warn emiss unintend radiat devic design manufactur exposur patient user person emiss unintend strai scatter radiat reduc instruct oper instruct devic emit radiat give detail inform natur emit radiat mean protect patient user wai avoid misus elimin risk inher instal ioniz radiat devic intend emit ioniz radiat design manufactur ensur practic quantiti geometri qualiti radiat emit vari control take account intend devic emit ioniz radiat intend diagnost radiolog design manufactur achiev imag output qualiti intend medic purpos whilst minim radiat exposur patient user devic emit ioniz radiat intend therapeut radiolog design manufactur enabl reliabl monitor control deliv dose beam type energi qualiti radiat requir medic devic connect equip energi sourc devic incorpor electron programm system design ensur repeat reliabl perform system intend event singl fault condit system mean adopt elimin reduc consequ risk devic safeti patient depend intern power suppli equip mean determin state power suppli devic safeti patient depend extern power suppli includ alarm system signal power failur devic intend monitor clinic paramet patient equip alarm system alert user situat lead death sever deterior patient state health devic design manufactur minim risk creat electromagnet field impair oper devic equip usual environ protect electr risk devic design manufactur avoid risk accident electr shock normal singl fault condit provid devic instal correctli protect mechan thermal risk devic design manufactur protect patient user mechan risk connect resist stabil move part 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 lowest level 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 construct minim risk access part devic exclud part area intend suppli heat reach temperatur surround attain potenti danger temperatur normal protect risk pose patient energi suppli substanc devic suppli patient energi substanc design construct flow rate set maintain accur guarante safeti patient user devic fit mean prevent indic inadequaci flow rate pose danger devic incorpor suitabl mean prevent accident releas danger level energi energi substanc sourc function control indic devic devic bear instruct requir oper oper adjust paramet mean visual system inform understand user patient inform suppli manufactur devic accompani inform need safe identifi manufactur take account train knowledg potenti user inform compris detail label data instruct practic inform need devic safe set devic packag unit sale packag individu packag unit practic inform set leaflet suppli devic instruct includ packag devic except instruct need devic class iia safe instruct inform form symbol symbol identif colour conform harmon standard area standard exist symbol colour document suppli devic label bear particular trade address manufactur devic import commun view distribut commun label outer packag instruct addit address person respons refer articl author repres manufactur establish commun import establish commun detail strictli user identifi devic content packag word steril batch code preced word lot serial number indic date devic safeti express year month indic devic singl devic costum made word custom made devic devic intend clinic investig word exclus clinic investig special storag handl condit special oper instruct warn precaut year manufactur activ devic cover indic includ batch serial number applic method steril intend purpos devic obviou user manufactur state label instruct reason practic devic detach compon identifi term batch action detect potenti risk pose devic detach compon instruct particular detail refer section except perform refer section undesir side effect devic instal connect medic devic equip order oper requir intend purpos suffici detail characterist identifi correct devic equip order obtain safe combin inform need verifi devic properli instal oper correctli safe detail natur frequenc mainten calibr need ensur devic oper properli safe time inform avoid risk connect implant devic inform risk reciproc interfer pose presenc devic specif investig treatment instruct event damag steril packag detail method resteril devic reusabl inform process reus includ clean disinfect packag method steril devic resteril restrict number reus devic suppli intent steril instruct clean steril correctli devic compli requir section detail treatment handl need devic steril final assembl case devic emit radiat medic purpos detail natur type intens distribut radiat instruct includ detail allow medic staff patient contra indic precaut detail cover precaut event perform devic precaut exposur forese environment condit magnet field extern electr influenc electrostat discharg pressur variat pressur acceler thermal ignit sourc adequ inform medicin product product devic question design administ includ limit choic substanc deliv precaut special unusu risk relat dispos devic medicin substanc incorpor devic integr part accord section degre accuraci claim devic measur function conform essenti requir base clinic data section data establish accord annex oj direct amend direct eec oj annex ii ec declar conform full qualiti assur system manufactur ensur applic qualiti system approv design manufactur final inspect product concern section subject audit laid section commun surveil section declar conform procedur manufactur fulfil oblig impos section ensur declar product concern meet provis direct appli manufactur affix ce mark accord articl draw written declar conform declar cover number product manufactur manufactur qualiti system manufactur lodg applic assess qualiti system notifi bodi applic includ address manufactur addit manufactur site cover qualiti system relev inform product product categori cover procedur written declar applic lodg notifi bodi product 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 undertak includ oblig manufactur notifi compet author incid immedi learn malfunct deterior characterist perform devic inadequaci instruct lead led death patient user deterior state health ii technic medic reason connect characterist perform devic lead reason refer subparagraph systemat recal devic type manufactur applic qualiti system ensur product 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 organ busi organiz structur respons manageri staff organiz author qualiti design manufactur product concern method monitor effici oper qualiti system abil achiev desir qualiti design product includ control product fail conform procedur monitor verifi design product gener descript product includ variant plan design specif includ standard appli result risk analysi descript solut adopt fulfil essenti requir appli product standard refer articl appli full techniqu control verifi design process systemat measur product design devic connect devic order oper intend proof provid conform essenti requir connect devic characterist manufactur statement indic devic incorpor integr part substanc refer section annex data test conduct connect clinic data refer annex draft label instruct inspect qualiti assur techniqu manufactur stage process procedur steril purchas relev document product identif procedur drawn date draw specif relev document stage manufactur test trial carri manufactur frequenc place test equip trace back calibr test equip adequ notifi bodi audit qualiti system determin meet requir refer section presum qualiti system implement relev harmon standard conform requir assess team includ number 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 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 addit oblig impos section manufactur lodg notifi bodi applic examin design dossier relat product plan manufactur fall categori refer section applic describ design manufactur perform product question includ document need assess product conform requir direct refer section notifi bodi examin applic product 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 product case devic refer annex paragraph notifi bodi view aspect address paragraph consult compet bodi establish member state accord direct eec take decis notifi bodi give due consider view express consult make decis convei final decis compet bodi concern approv design receiv approv notifi bodi issu ec design examin certif affect conform essenti requir direct condit prescrib product applic inform notifi bodi issu ec design examin certif made approv design addit approv form supplement ec design examin certif surveil aim surveil ensur manufactur duli fulfil oblig impos approv qualiti system manufactur author 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 administr provis manufactur period end year product manufactur dispos nation author declar conform document refer fourth indent section refer section document refer section decis report notifi bodi refer section notifi bodi make notifi bodi compet author request relev inform qualiti system approv issu refus withdrawn respect devic subject procedur section manufactur author repres establish commun oblig technic document fall person respons place devic commun market import refer annex section applic devic class iia iib line articl annex appli product class iia iib section appli annex iii ec type examin ec type examin procedur notifi bodi ascertain certifi repres sampl product cover fulfil relev provis direct applic includ address manufactur address author 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 product item gener descript type includ variant plan design draw method manufactur envisag steril diagram compon assembl circuit descript explan understand abovement draw diagram oper product list standard refer articl appli full part descript solut adopt meet essenti requir standard refer articl appli full result design calcul risk analysi investig technic test carri statement indic devic incorpor integr part substanc refer section annex data test conduct connect clinic data refer annex draft label instruct 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 carri arrang inspect test verifi solut adopt manufactur meet essenti requir direct standard refer articl appli devic connect devic order oper intend proof provid conform essenti requir connect devic characterist manufactur carri arrang inspect test verifi manufactur chosen appli relev standard appli agre applic place inspect test cari type conform provis direct notifi bodi issu applic ec type examin certif certif address manufactur conclus inspect condit valid data need identif type approv relev part document annex certif copi notifi bodi case devic refer annex paragraph notifi bodi view aspect address paragraph consult compet bodi establish member state accord direct eec take decis notifi bodi give due consider view express consult make decis convei final decis compet bodi concern applic inform notifi bodi issu ec type examin certif signific chang made approv product approv product receiv approv notifi bodi issu ec type examin certif affect conform essenti requir condit prescrib product approv form supplement initi ec type examin certif administr provis notifi bodi make notifi bodi request relev inform ec type examin certif supplement issu refus withdrawn notifi bodi obtain copi ec type examin certif supplement thereto annex certif made notifi bodi reason applic manufactur inform manufactur author repres technic document copi ec type examin certif addit period end year devic manufactur manufactur author repres establish commun oblig technic document fall person respons place devic commun market import refer annex section annex iv ec verif ec verif procedur manufactur author repres establish commun 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 steril routin pre establish provis implement ensur homogen product conform product type ec type examin certif requir direct appli manufactur affix ce mark accord articl draw declar conform addit product market steril condit aspect manufactur process design secur maintain steril manufactur appli provis annex section manufactur undertak institut date systemat procedur review experi gain devic post product phase implement mean appli correct action undertak includ oblig manufactur notifi compet author incid immedi learn malfunct deterior characterist perform devic inadequaci label instruct lead led death patient user deterior state health ii technic medic reason connect characterist perform devic reason refer subparagraph lead systemat recal devic type manufactur notifi bodi carri examin test order verifi conform product requir direct examin test product section examin test product statist basi section manufactur decid aforement check appli aspect manufactur process design secur steril 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 individu 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 entail sampl system ensur limit qualiti probabl accept conform percentag sampl method establish harmon 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 administr provis manufactur author repres period end year product manufactur make nation author declar conform document refer section certif refer section type examin certif refer annex iii applic devic class iia line articl annex appli product class iia subject exempt derog section virtu declar conform manufactur ensur declar product class iia manufactur conform technic document refer section annex vii meet requir direct appli derog section verif conduct notifi bodi intend confirm conform product class iia technic document refer section annex vii annex ec declar conform product qualiti assur manufactur ensur applic qualiti system approv manufactur product concern carri final inspect section subject commun 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 written declar conform declar cover number identifi specimen product manufactur manufactur qualiti system manufactur lodg applic assess qualiti system notifi bodi applic includ address manufactur relev inform product product categori cover procedur written declar applic lodg notifi bodi product document qualiti system undertak fulfil oblig impos qualiti system approv undertak maintain practic effect approv qualiti system technic document type approv copi ec type examin certif undertak manufactur institut date systemat procedur review experi gain devic post product phase implement mean appli correct action undertak includ oblig manufactur notifi compet author incid immedi learn malfunct deterior characterist perform devic inadequaci label instruct lead led death patient user deterior state health ii technic medic reason connect characterist perform devic reason refer subparagraph lead systemat recal devic type manufactur applic qualiti system ensur product 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 organ busi organiz structur respons manageri staff organiz author manufactur product concern method monitor effici oper qualiti system abil achiev desir qualiti product includ control product fail conform inspect qualiti assur techniqu manufactur stage process procedur steril purchas relev document product identif procedur drawn date draw specif relev document stage manufactur test trial carri manufactur frequenc place test equip adequ trace back calibr test equip notifi bodi audit qualiti system determin meet requir refer section presum qualiti system implement relev harmon standard conform requir assess team includ member past experi assess technolog concern assess procedur includ inspect manufactur premis duli substanti case premis manufactur supplier inspect manufactur process decis notifi manufactur final inspect 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 abovement inform receiv decis notifi manufactur conclus inspect reason assess surveil aim surveil ensur manufactur duli fulfil oblig impos approv qualiti system manufactur author notifi bodi carri inspect suppli relev inform document qualiti system 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 administr provis manufactur period end year product manufactur make nation author declar conform document refer fourth indent section refer section document refer seventh indent section decis report notifi bodi refer section type examin certif refer annex iii notifi bodi make notifi bodi request relev inform qualiti system approv issu refus withdrawn applic devic class iia line articl annex appli product class iia subject exempt derog section virtu declar conform manufactur ensur declar product class iia manufactur conform technic document refer section annex vii meet requir direct appli annex vi ec declar conform product qualiti assur manufactur ensur applic qualiti system approv final inspect test product section subject surveil refer section addit product market steril condit aspect manufactur process design secur maintain steril manufactur appli provis annex 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 written declar conform declar cover number identifi specimen product manufactur manufactur ce mark accompani identif number notifi bodi perform task refer annex qualiti system manufactur lodg applic assess qualiti system notifi bodi applic includ address manufactur relev inform product product categori cover procedur written declar applic lodg notifi bodi product document qualiti system undertak manufactur fulfil oblig impos qualiti system approv undertak manufactur approv qualiti system adequ efficaci technic document type approv copi ec type examin certif undertak manufactur institut date systemat procedur review experi gain devic post product phase implement mean appli correct action undertak includ oblig manufactur notifi compet author incid immedi learn malfunct deterior characterist perform devic inadequaci label instruct lead led death patient user deterior state health ii technic medic reason connect characterist perform devic reason refer subparagraph lead systemat recal devic type manufactur qualiti system product repres sampl batch examin test defin relev standard refer articl equival test carri ensur product conform type ec type examin certif fulfil provis direct appli element requir provis adopt manufactur document systemat orderli manner form written measur procedur instruct qualiti system document permit uniform interpret qualiti programm qualiti plan qualiti manual qualiti record includ adequ descript qualiti object organiz structur respons power manageri staff regard product qualiti examin test carri manufactur trace back calibr test equip adequ method monitor effici oper qualiti system qualiti record report inspect test calibr qualif staff concern aforement check appli aspect manufactur process design secur steril notifi bodi audit qualiti system determin meet requir refer section presum qualiti system implement relev harmon standard conform requir assess team includ member past experi assess technolog concern assess procedur includ inspect manufactur premis duli substanti case premis manufactur supplier 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 receiv abovement inform notifi manufactur decis decis conclus inspect reason assess surveil aim surveil ensur manufactur duli fulfil oblig impos approv qualiti system manufactur notifi bodi access inspect purpos inspect test storag locat suppli relev inform document qualiti system technic document qualiti record inspect report test data calibr data qualif report staff concern notifi bodi period carri inspect assess make manufactur appli 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 product conform requir direct appli end adequ sampl final product site notifi bodi examin test defin relev standard refer articl equival test carri sampl fail conform notifi bodi measur provid manufactur inspect report test carri test report administr provis manufactur period end year product manufactur make nation author declar conform document refer seventh indent section refer section decis report notifi bodi refer final indent section section certif conform refer annex iii notifi bodi make notifi bodi request relev inform qualiti system approv issu refus withdrawn applic devic class iia line articl annex appli product class iia subject derog derog section virtu declar conform manufactur ensur declar product class iia manufactur conform technic document refer section annex vii meet requir direct appli annex vii ec declar conform ec declar conform procedur manufactur author repres establish commun fulfil oblig impos section case product market steril condit devic measur function oblig impos section ensur declar product concern meet provis direct appli manufactur prepar technic document section manufactur author repres establish commun make document includ declar conform nation author inspect purpos period end year product manufactur manufactur author repres establish commun oblig technic document fall person place product commun market technic document assess conform product requir direct includ gener descript product includ variant plan design draw method manufactur envisag diagram compon assembl circuit descript explan understand abovement 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 product market steril condit descript method result design calcul inspect carri devic connect devic order oper intend proof provid conform essenti requir connect devic characterist manufactur test report clinic data accord annex label instruct 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 deterior characterist perform devic inadequaci label instruct lead led death patient user deterior state health ii technic medic reason connect characterist perform devic reason refer subparagraph lead systemat recal devic type manufactur product market steril condit class devic measur function manufactur observ provis laid annex procedur refer annex iv vi applic abovement annex intervent notifi bodi limit case product market steril condit aspect manufactur concern secur maintain steril condit case devic measur function aspect manufactur concern conform product metrolog requir section annex applic applic devic class iia line articl annex appli product class iia subject derog annex appli conjunct procedur refer annex iv vi declar conform refer abovement annex form singl declar declar base annex manufactur ensur declar product design meet provis direct appli annex viii statement devic special purpos custom made devic devic intend clinic investig manufactur author repres establish commun draw statement inform stipul section statement inform custom made devic data allow identif devic question statement devic intend exclus patient patient medic practition author person made prescript applic clinic concern featur devic relev medic prescript statement devic question conform essenti requir set annex applic indic essenti requir fulli met ground devic intend clinic investig cover annex data allow identif devic question investig plan state purpos scientif technic medic ground scope number devic concern opinion ethic committe concern detail aspect cover opinion medic practition author person institut respons investig place start date schedul durat investig statement devic question conform essenti requir aspect cover investig regard aspect precaut protect health safeti patient manufactur undertak compet nation author custom made devic document allow understand design manufactur perform product includ expect perform assess conform requir direct manufactur measur ensur manufactur process produc product manufactur accord document mention paragraph devic intend clinic investig document gener descript product design draw method manufactur envisag steril diagram compon assembl circuit descript explan understand abovement 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 result design calcul inspect technic test carri manufactur measur ensur manufactur process produc product manufactur accord document refer paragraph section manufactur author assess audit effect measur inform contain declar concern annex period time year annex ix classif criteria definit definit classif rule durat transient intend continu minut short term intend continu dai long term intend continu dai invas devic invas devic devic part penetr insid bodi bodi orific surfac bodi bodi orific natur open bodi extern surfac eyebal perman artifici open stoma surgic invas devic invas devic penetr insid bodi surfac bodi aid context surgic oper purpos direct devic refer previou subparagraph produc penetr establish bodi orific treat surgic invas devic implant devic devic intend total introduc human bodi replac epitheli surfac surfac ey surgic intervent intend remain place procedur devic intend partial introduc human bodi surgic intervent intend remain place procedur dai consid implant devic reusabl surgic instrument instrument intend surgic cut drill saw scratch scrape clamp retract clip similar procedur connect activ medic devic reus procedur carri activ medic devic medic devic oper depend sourc electr energi sourc power directli gener human bodi graviti act convert energi medic devic intend transmit energi substanc element activ medic devic patient signific chang consid activ medic devic activ therapeut devic activ medic devic combin medic devic support modifi replac restor biolog function structur view treatment allevi ill injuri handicap activ devic diagnosi activ medic devic combin medic devic suppli inform detect diagnos monitor treat physiolog condit state health ill congenit deform central circulatori system purpos direct central circulatori system mean vessel arteria pulmonal aorta ascenden arteria coronaria arteria caroti communi arteria caroti externa arteria caroti interna arteria cerebral truncu brachicephalicu vena cordi vena pulmonal vena cava superior vena cava inferior central nervou system purpos direct central nervou system mean brain mening spinal cord ii implement rule implement rule applic classif rule govern intend purpos devic devic intend combin devic classif rule appli separ devic accessori classifi separ devic softwar drive devic influenc devic fall automat class devic intend sole princip specif part bodi consid classifi basi critic rule appli devic base perform devic manufactur strictest rule result higher classif appli iii classif invas devic rule invas devic class rule set hereinaft appli rule invas devic intend channel store blood bodi liquid tissu liquid gase purpos eventu infus administr introduct bodi class iia connect activ medic devic class iia higher class intend store channel blood bodi liquid store organ part organ bodi tissu case class rule invas devic intend modifi biolog chemic composit blood bodi liquid liquid intend infus bodi class iib treatment consist filtrat centrifug exchang ga heat case class iia rule invas devic contact injur skin class intend mechan barrier compress absorpt exud class iib intend princip wound breach dermi heal secondari intent class iia case includ devic princip intend manag micro environ wound invas devic rule invas devic respect bodi orific surgic invas devic intend connect activ medic devic class intend transient class iia intend short term oral caviti pharynx ear canal ear drum nasal caviti case class class iib intend long term oral caviti pharynx ear canal ear drum nasal caviti liabl absorb mucou membran case class iia invas devic respect bodi orific surgic invas devic intend connect activ medic devic class iia higher class class iia rule surgic invas devic intend transient class iia intend specif diagnos monitor correct defect heart central circulatori system direct contact part bodi case class iii reusabl surgic instrument case class intend suppli energi form ioniz radiat case class iib intend biolog effect wholli absorb case class iib intend administ medicin mean deliveri system manner potenti hazard take account mode applic class iib rule surgic invas devic intend short term class iia intend specif diagnos monitor correct defect heart central circulatori system direct contact part bodi case class iii specif direct contact central nervou system case class iii suppli energi form ioniz radiat case class iib biolog effect wholli absorb case class iii undergo chemic chang bodi devic teeth administ medicin case class iib rule implant devic long term surgic invas devic class iib intend teeth case class iia direct contact heart central circulatori system central nervou system case class iii biolog effect wholli absorb case class iii undergo chemic chang bodi devic teeth administ medicin case class iii addit rule applic activ devic rule activ therapeut devic intend administ exchang energi class iia characterist administ exchang energi human bodi potenti hazard take account natur densiti site applic energi case class iib activ devic intend control monitor perform activ therapeut devic class iib intend directli influenc perform devic class iib rule activ devic intend diagnosi class iia intend suppli energi absorb human bodi devic illumin patient bodi visibl spectrum intend imag vivo distribut radiopharmaceut intend direct diagnosi monitor vital physiolog process specif intend monitor vital physiolog paramet natur variat result danger patient instanc variat cardiac perform respir activ cn case class iib activ devic intend emit ioniz radiat intend diagnost therapeut intervent radiolog includ devic control monitor devic directli influenc perform class iib rule activ devic intend administ remov medicin bodi liquid substanc bodi class iia manner potenti hazard take account natur substanc involv part bodi concern mode applic case class iib rule activ devic class special rule rule devic incorpor integr part substanc separ consid medicin product defin articl direct eec liabl act human bodi action ancillari devic class iii rule devic contracept prevent transmiss sexual transmit diseas class iib implant long term invas devic case class iii rule devic intend specif disinfect clean rins hydrat contact lens class iib devic intend specif disinfect medic devic class iia rule appli product intend clean medic devic contact lens mean physic action rule activ devic specif intend record rai diagnost imag class iia rule devic manufactur util anim tissu deriv render viabl class iii devic intend contact intact skin rule derog rule blood bag class iib annex clinic evalu gener provis gener rule confirm conform requir characterist perform refer section annex normal condit devic evalu undesir side effect base clinic data case implant devic devic class iii take account relev harmon standard adequaci clinic data base compil relev scientif literatur intend purpos devic techniqu emploi written report critic evalu compil result clinic investig made includ carri conform section data remain confidenti accord provis articl clinic investig object object clinic investig verifi normal condit perform devic conform refer section annex determin undesir side effect normal condit assess constitut risk weigh intend perform devic ethic consider clinic investig carri accord helsinki declar adopt world medic assembl helsinki finland amend st world medic assembl hong kong mandatori measur relat protect human subject carri spirit helsinki declar includ step clinic investig consider justif studi public result method clinic investig perform basi plan investig reflect latest scientif technic knowledg defin confirm refut manufactur claim devic investig includ adequ number observ guarante scientif valid conclus procedur perform investig devic examin clinic investig perform circumst similar normal condit devic featur includ involv safeti perform devic effect patient examin advers incid articl fulli record notifi compet author investig perform respons medic practition author qualifi person environ medic practition author person access technic clinic data devic written report sign medic practition author person respons critic evalu data collect clinic investig annex xi criteria met design notifi bodi notifi bodi director assess verif staff design manufactur supplier instal user devic inspect author 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 annex notifi bodi dispos nation author relev document assess subcontractor qualif work carri subcontractor direct notifi bodi carri task assign bodi annex ii vi notifi task carri bodi respons staff possess facil need perform properli technic administr task entail assess verif access equip verif requir notifi bodi 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 notifi bodi guarante remuner depend number inspect carri result inspect bodi civil liabil insur liabil assum state domest legisl member state carri inspect directli staff notifi bodi bound observ profession secreci regard inform gain duti vi vi compet administr author state activ carri pursuant direct provis nation law put effect annex xii ce mark conform ce conform mark consist initi ce take form mark reduc enlarg proport graduat draw respect compon ce mark substanti vertic dimens mm minimum dimens waiv small scale devic