council direct june approxim law member state relat activ implant medic devic eec council european commun regard treati establish european econom commun articl thereof regard propos commiss cooper european parliament regard opinion econom social committe member state activ implant medic devic give patient user person high level protect achiev intend level perform implant human be member state sought ensur level safeti mandatori specif relat technic safeti featur inspect procedur devic specif differ member state nation provis ensur safeti level harmon order guarante free movement activ implant medic devic lower exist justifi level safeti member state harmon measur distinguish measur member state manag financ public health sick insur scheme directli indirectli devic provis affect member state implement abovement measur complianc commun law maintain improv level protect achiev member state constitut direct essenti object defin essenti requir rule govern activ implant medic devic confin provis need satisfi oj essenti requir essenti requir replac nation provis order facilit proof conform essenti requir permit monitor conform desir europ wide harmon standard respect prevent risk connect design manufactur packag activ implant medic devic standard harmon european level 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 bodi instruct commiss pursuant provis council direct eec march lai procedur provis inform field technic standard regul amend direct eec abovement gener guidelin evalu procedur establish accept common accord member state accord commun criteria specif natur medic sector make advis make provis notifi bodi manufactur agent establish commun fix common accord time limit complet evalu verif oper conform devic adopt direct articl direct appli activ implant medic devic purpos direct definit appli medic devic mean instrument apparatu applianc materi articl combin accessori softwar proper function intend manufactur human be diagnosi prevent monitor treatment allevi diseas injuri investig replac modif anatomi physiolog process control concept achiev princip intend action pharmacolog chemic immunolog metabol mean assist function mean activ medic devic mean medic devic reli function sourc electr energi sourc power directli gener human bodi graviti activ implant medic devic mean activ medic devic intend total partial introduc surgic medic human bodi medic intervent natur orific intend remain procedur custom made devic mean activ implant medic devic specif made accord medic specialist written prescript respons specif design characterist intend individu name patient devic intend clinic investig mean activ implant medic devic intend specialist doctor conduct investig adequ human clinic environ intend purpos mean medic devic intend suit data suppli manufactur instruct put servic mean make medic profess implant activ implant medic devic intend administ substanc defin medicin product mean council direct eec januari approxim provis laid law regul administr action relat proprietari medicin product amend direct eec substanc subject system market author provid direct activ implant medic devic incorpor integr part substanc separ consid medicin product mean articl direct eec devic evalu author accord provis direct direct constitut specif direct mean articl council direct eec approxim law member state relat electromagnet compat articl member state step ensur devic refer articl market put servic compromis safeti health patient user applic person properli implant maintain accord intend purpos articl activ implant medic devic refer articl hereinaft refer devic satisfi essenti requir set annex appli account intend purpos devic concern articl member state imped place market put servic territori devic bear ce mark member state creat obstacl devic intend clinic investig made specialist doctor purpos satisfi condit laid articl annex custom made devic market put servic satisfi condit laid annex accompani statement refer annex devic bear ce mark trade fair exhibit demonstr member state prevent show devic conform direct provid visibl sign devic conform put servic made compli manufactur author repres establish commun devic put servic member state requir inform section annex nation languag articl 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 articl member state commiss consid harmon standard refer articl meet essenti requir refer articl commiss member state concern bring matter stand committe set direct eec give reason therefor committe deliv opinion delai light opinion committe commiss inform member state measur regard standard public refer articl stand committe hereinaft refer committe set compos repres member state chair repres commiss committe draw rule procedur matter relat implement practic applic direct brought committe accord procedur set repres commiss submit committe draft measur committe deliv opinion 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 member state find devic refer articl correctli put servic accord intend purpos compromis health safeti patient user applic person 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 devic meet full part standard refer articl incorrect applic standard 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 devic compli bear ce mark compet member state action whomsoev affix mark inform commiss member state thereof commiss ensur member state inform progress outcom procedur articl member state step ensur inform brought knowledg incid mention involv devic record evalu central manner deterior characterist perform devic inaccuraci instruct leaflet lead led death patient deterior state health technic medic reason result withdraw devic market manufactur member state prejudic articl forthwith inform commiss member state incid refer paragraph relev measur contempl articl case devic custom made intend clinic investig manufactur order affix ce mark choic follow procedur relat ec declar conform set annex follow procedur relat ec type examin set annex coupl procedur relat ec verif set annex ii procedur relat ec declar conform type set annex case custom made devic manufactur draw declar provid annex place devic market procedur provid annex discharg manufactur author repres establish commun record correspond relat procedur refer paragraph offici languag member state procedur carri languag accept notifi bodi defin articl articl case devic intend clinic investig manufactur author repres establish commun dai commenc investig submit statement refer annex compet author member state investig conduct manufactur commenc relev clinic investig end period dai notif compet author notifi period decis contrari base consider public health public order member state step ensur public health order articl member state notifi member state commiss bodi design carri task pertain procedur refer articl specif task bodi design identifi logo bodi hereinaft refer notifi bodi commiss publish list notifi bodi task notifi offici journal european commun ensur list date member state appli minimum criteria set annex design bodi bodi satisfi criteria fix relev harmon standard presum satisfi relev minimum criteria member state notifi bodi withdraw notif find bodi longer meet criteria refer paragraph immedi inform member state commiss thereof notifi bodi manufactur agent establish commun fix common accord time limit complet evalu verif oper refer annex articl devic custom made intend clinic investig consid meet essenti requir refer articl bear ec mark conform ec mark conform shown annex visibl legibl indel form steril pack sale packag instruct leaflet accompani logo notifi bodi respons implement procedur set annex affix mark confus ec mark conform prohibit articl establish ec mark wrongli affix respect devic conform relev standard refer articl manufactur opt conform therewith conform approv type conform approv type meet relev essenti requir manufactur fail fulfil oblig relev ec declar conform notifi bodi measur forthwith inform compet member state thereof articl decis pursuant direct result refus restrict place market put servic devic state exact ground base decis notifi delai parti concern time inform remedi law forc member state question time limit remedi subject articl 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 articl juli member state adopt publish law regul administr provis order compli direct forthwith inform commiss thereof appli provis januari member state commun commiss text provis nation law adopt field cover direct member state period decemb permit place market put servic devic compli nation rule forc territori decemb articl direct address member state luxembourg june council presid mallei oj oj oj oj oj oj oj oj annex essenti requir gener requir devic design manufactur implant condit purpos laid compromis clinic condit safeti patient present risk person implant applic person devic achiev perform intend manufactur design manufactur suitabl function refer articl characterist perform refer section advers affect degre clinic condit safeti patient person compromis lifetim devic anticip manufactur devic subject stress occur normal condit devic design manufactur pack characterist perform advers affect storag transport condit laid manufactur temperatur humid side effect undesir condit constitut accept risk weigh perform intend ii requir design construct solut adopt manufactur design construct devic compli safeti principl take account gener acknowledg state art implant devic design manufactur pack reusabl pack procedur ensur steril market storag transport condit stipul manufactur remain packag remov implant devic design manufactur remov minim risk physic injuri connect physic includ dimension featur risk connect energi sourc refer electr insul leakag current overh devic risk connect forese environment condit magnet field extern electr influenc electrostat discharg pressur variat pressur acceler risk connect medic treatment result defibril high frequenc surgic equip risk connect ioniz radiat radioact substanc includ devic complianc protect requir laid direct euratom amend direct euratom euratom risk aris mainten calibr imposs includ excess increas leakag current ag materi excess heat gener devic decreas accuraci measur control mechan oj oj oj devic design manufactur guarante characterist perform refer gener requir attent paid choic materi toxic aspect mutual compat materi biolog tissu cell bodi fluid account anticip devic compat devic substanc intend administ qualiti connect respect safeti reliabl sourc energi leakproof proper function program control system includ softwar devic incorpor integr part substanc separ consid medicin product defin articl direct eec action combin devic result bioavail safeti qualiti us substanc account purpos devic verifi analog method direct eec amend direct eec devic compon part identifi measur discoveri potenti risk connect devic compon part devic bear code manufactur unequivoc identifi regard type devic year manufactur read code surgic oper devic accessori bear instruct requir oper devic oper adjust paramet mean visual system inform understand user patient devic bear legibl indel particular form gener recogn symbol steril pack method steril indic permit packag recogn address manufactur descript devic devic intend clinic investig word exclus clinic investig devic custom made word custom made devic declar implant devic steril condit month year manufactur indic time limit implant devic safe sale packag address manufactur descript devic purpos devic relev characterist devic intend clinic investig word exclus clinic investig oj oj devic custom made word custom made devic declar implant devic steril condit month year manufactur indic time limit implant devic safe condit transport store devic market devic accompani instruct give particular year author affix ce mark detail refer except refer eighth ninth indent perform refer section undesir side effect inform allow physician select suitabl devic softwar accessori inform constitut instruct allow physician patient devic accessori softwar correctli inform natur scope time oper control trial mainten measur inform allow risk connect implant devic avoid inform risk reciproc interfer connect presenc devic specif investig treatment instruct event steril pack damag detail method resteril indic devic reus recondit respons manufactur compli essenti requir instruct leaflet includ detail allow physician patient contra indic precaut detail cover inform allow lifetim energi sourc establish precaut occur devic perform precaut exposur forese environment condit magnet field extern electr influenc electrostat discharg pressur variat pressur acceler adequ inform medicin product devic question design administ confirm devic satisfi requir respect characterist perform refer gener requir normal condit evalu side effect undesir effect base clinic data establish accord annex risk reciproc interfer mean advers effect devic caus instrument present time investig treatment vice versa annex ec declar conform complet qualiti assur system manufactur appli qualiti system approv design manufactur final inspect product concern section subject ec surveil section declar conform procedur mean manufactur satisfi oblig section ensur declar product concern meet provis direct appli manufactur appli ce mark accord articl draw written declar conform declar cover identifi specimen product manufactur ce mark accompani identifi logo notifi bodi respons qualiti system manufactur make applic evalu qualiti system notifi bodi applic includ item inform categori product manufactur envisag qualiti system document undertak fulfil oblig aris qualiti system approv undertak maintain approv qualiti system remain adequ efficaci undertak manufactur institut date post market surveil system undertak includ oblig manufactur notifi compet author incid immedi learn deterior characterist perform inaccuraci instruct leaflet devic lead led death patient deterior state health ii technic medic reason result withdraw devic market manufactur applic qualiti system ensur product conform provis direct appli stage design final control element requir provis adopt manufactur qualiti system document systemat orderli manner form written polici procedur qualiti system document make uniform interpret qualiti 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 conform procedur monitor verifi design product design specif includ standard appli descript solut adopt fulfil essenti requir appli product standard refer articl appli full techniqu control verif design process systemat action product design techniqu control qualiti assur manufactur stage process procedur steril purchas relev document product identif procedur drawn date draw specif relev document stage manufactur test trial effect product frequenc place test equip prejudic articl direct notifi bodi effect audit qualiti system determin meet requir refer presum conform requir qualiti system harmon standard team entrust evalu includ member experi evalu technolog concern evalu procedur includ inspect manufactur premis decis notifi manufactur final inspect conclus control reason evalu manufactur inform notifi bodi approv qualiti system plan alter qualiti system notifi bodi evalu propos modif verifi qualiti system modifi meet requir refer notifi manufactur decis decis conclus control reason evalu examin design product addit oblig incumb section manufactur make applic examin design dossier relat product plan manufactur fall categori refer applic describ design manufactur perform product question includ particular make evalu compli requir direct includ inter alia design specif includ standard appli proof appropri standard refer articl appli full proof includ result test carri manufactur carri respons statement devic incorpor integr part substanc refer section annex action combin devic result bioavail data relev trial conduct clinic data refer annex draft instruct leaflet notifi bodi examin applic product compli relev provis direct issu applic ec design examin certif notifi bodi requir applic supplement test proof complianc requir direct evalu certif conclus examin condit valid data need identif approv design descript intend product applic inform notifi bodi issu ec design examin certif modif made approv design modif made approv design obtain supplementari approv notifi bodi issu ec design examin certif modif affect conform essenti requir direct condit prescrib product supplementari approv form addendum ec design examin certif surveil aim surveil ensur manufactur duli fulfil oblig aris approv qualiti system manufactur author notifi bodi carri inspect suppli inform qualiti system document data stipul part qualiti system relat design result analys calcul test data stipul part qualiti system relat manufactur report inspect test standard calibr qualif staff concern notifi bodi period carri inspect evalu order ascertain manufactur appli approv qualiti system suppli manufactur evalu report addit notifi bodi make unannounc visit manufactur suppli inspect report notifi bodi commun notifi bodi relev inform approv qualiti system issu refus withdrawn annex ec type examin ec type examin procedur notifi bodi observ certifi repres sampl product envisag satisfi relev provis direct applic ec type examin made manufactur author repres establish commun notifi bodi applic includ address manufactur address author repres applic made written declar applic made notifi bodi document section need evalu made conform repres sampl product question hereinaft refer type requir direct applic make type notifi bodi notifi bodi request sampl document make understand design manufactur perform product document item gener descript type design draw method manufactur envisag steril diagram part assembl circuit descript explan understand abovement draw diagram oper product list standard refer articl appli full part descript solut adopt satisfi essenti requir standard refer articl appli result design calcul investig technic test carri statement devic incorpor integr part substanc refer section annex action combin devic result bioavail data relev trial conduct clinic data refer annex draft instruct leaflet notifi bodi examin evalu document verifi type manufactur accord document record item design accord applic provis standard refer articl item design base relev provis standard carri carri inspect test verifi solut adopt manufactur satisfi essenti requir direct standard refer articl appli carri carri inspect test verifi manufactur chosen appli relev standard appli agre applic place inspect test carri type meet provis direct notifi bodi issu ec type examin certif applic certif address manufactur conclus control condit certif valid inform identif type approv signific part document attach certif copi notifi bodi applic inform notifi bodi issu ec type examin certif modif made approv product modif approv product receiv approv notifi bodi issu ec type examin certif modif affect conform essenti requir condit product approv issu form supplement initi ec type examin certif notifi bodi commun notifi bodi relev inform ec type examin certif supplement issu refus withdrawn notifi bodi obtain copi ec type examin certif supplement annex certif made notifi bodi reason applic made inform manufactur annex ec verif ec verif act notifi bodi verifi certifi product conform type ec type examin certif satisfi relev requir direct manufactur start manufactur prepar document defin manufactur process steril routin pre establish provis implement ensur homogen product conform product type ec type examin certif relev requir direct manufactur undertak institut date post market surveil system undertak includ oblig manufactur notifi compet author event immedi learn deterior characterist perform inaccuraci instruct leaflet devic lead led death patient deterior state health ii technic medic reason result withdraw devic market manufactur notifi bodi carri ec verif control test product statist basi manufactur author notifi bodi evalu effici measur pursuant section audit 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 order determin batch accept reject statist control product base attribut entail sampl system characterist level qualiti probibl accept conform percentag limit qualiti probabl accept conform percentag batch accept notifi bodi draw written certif conform product batch market except product sampl found conform batch reject notifi bodi respons measur prevent batch market justifi practic ground manufactur affix ce mark manufactur respons notifi bodi accord articl accompani identifi logo notifi bodi respons statist verif annex ec declar conform type assur product qualiti manufactur appli qualiti system approv manufactur conduct final inspect product concern subject surveil refer section declar conform procedur element manufactur satisfi oblig section guarante 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 identifi specimen product manufactur ce mark accompani identifi logo notifi bodi respons qualiti system manufactur make applic evalu qualiti system notifi bodi applic includ inform product intend manufactur qualiti system document undertak fulfil oblig aris qualiti system approv undertak maintain approv qualiti system remain adequ efficaci technic document relat approv type copi ec type examin certif undertak manufactur institut date post market surveil system undertak includ oblig manufactur notifi compet author incid immedi learn deterior characterist perform inaccuraci instruct leaflet devic lead led death patient deterior state health ii technic medic reason result withdraw devic market 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 procedur qualiti system document make uniform interpret qualiti 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 manufactur product concern method monitor effici oper qualiti system abil achiev desir qualiti design product includ control product conform techniqu control qualiti assur manufactur stage process procedur steril purchas relev document product identif procedur drawn date draw specif relev document stage manufactur test trial effect product frequenc place test equip prejudic articl notifi bodi effect audit qualiti system determin meet requir refer presum conform requir qualiti system harmon standard team entrust evalu includ member experi evalu technolog concern evalu procedur includ inspect manufactur premis decis notifi manufactur final inspect conclus control reason evalu manufactur inform notifi bodi approv qualiti system plan alter system notifi bodi evalu propos modif verifi qualiti system modifi meet requir refer notifi manufactur decis decis conclus control reason evalu surveil aim surveil ensur manufactur duli fulfil oblig aris approv qualiti system manufactur author notifi bodi carri inspect suppli inform qualiti system document data stipul part qualiti system relat manufactur report inspect test standard calibr qualif staff concern notifi bodi period carri inspect evalu order ascertain manufactur appli approv qualiti system suppli manufactur evalu report addit notifi bodi make unannounc visit manufactur suppli inspect report notifi bodi commun notifi bodi relev inform approv qualiti system issu refus withdrawn annex statement devic intend special purpos manufactur author repres establish commun draw custom made devic devic intend clinic investig statement compris element stipul section statement compris inform custom made devic data allow devic question identifi statement affirm devic intend exclus patient doctor drew prescript applic clinic concern featur devic medic prescript concern statement affirm devic compli essenti requir annex applic indic essenti requir wholli met ground devic intend clinic investig cover annex data allow devic question identifi investig plan give purpos scope number devic concern doctor institut respons investig place date commenc durat schedul investig statement affirm devic question compli essenti requir aspect constitut object investig regard aspect precaut protect health safeti patient manufactur undertak compet nation author custom made devic document enabl design manufactur perform product includ expect perform understood conform requir direct assess manufactur measur manufactur process ensur product manufactur conform document refer paragraph devic intend clinic investig document gener descript product design draw manufactur method steril diagram part assembl circuit descript explan understand draw diagram oper product list standard laid articl appli full part descript solut adopt satisfi essenti requir direct standard articl appli result design calcul check technic test carri manufactur measur manufactur process ensur product manufactur conform document refer paragraph section manufactur author evalu audit effect measur annex clinic evalu gener provis adequaci clinic data present refer section annex section annex base account relev harmon standard collat relev scientif literatur cover intend devic techniqu therefor written report make critic assess collat result clinic investig made includ carri accord section data remain confidenti deem essenti divulg clinic investig purpos purpos clinic investig verifi normal condit perform devic compli section annex determin undesir side effect normal condit assess accept risk regard intend perform devic ethic consider clinic investig made accord declar helsinki approv world medic assembl helsinki finland amend world medic assembl tokyo japan world medic assembl venic itali mandatori measur relat protect human subject carri spirit declar helsinki includ step clinic investig consider justif studi public result method clinic investig perform state art plan investig defin confirm refut manufactur claim devic investig includ adequ number observ guarante scientif valid conclus procedur util perform investig devic examin clinic investig perform circumst equival found normal condit devic featur includ involv safeti perform devic effect patient examin advers event fulli record investig perform respons appropri qualifi medic specialist environ medic specialist access technic data devic written report sign respons medic specialist compris critic evalu data collect clinic investig annex minimum criteria met design inspect bodi notifi bodi director staff respons carri evalu verif oper design manufactur supplier instal devic control author repres parti directli involv design construct market mainten devic repres parti engag activ preclud possibl exchang technic inform manufactur bodi bodi staff carri evalu verif oper highest degre profession integr technic compet free pressur induc financi influenc judgement result inspect person group person interest result verif bodi carri task annex assign bodi notifi task carri bodi respons dispos staff possess facil enabl perform properli technic administr task connect evalu verif access equip verif requir staff respons control oper sound vocat train cover evalu verif oper bodi design satisfactori knowledg requir control carri adequ experi oper abil requir draw certif record report demonstr control carri imparti inspect staff guarante remuner depend number control carri result control bodi liabil insur liabil assum state accord nation law member state directli respons control staff bodi bound observ profession secreci regard inform gain carri task vi vi compet administr author state activ carri direct provis nation law give effect annex ce mark conform