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"   SamkvmtlgumumheilbrigWisYj;nustu,nr.97/1990,ferheilbrigWisogtryggingamla # rWuneytiWmeWyfirstj;rnheilbrigWismlaogsamkvmtsmulgumannastlandlknirtil  $ teknamlaflokkafyrirhndrWherraoghefureftirlitmeWstarfiogstarfsaWstWuheilbrigWis !W% sttta.LandlknirsreinnigumfaglegteftirlitmeWheilbrigWisstofnunumo.fl.0framan  J""&  greindumkvWumfelsteftirlitmeWlkningatkjum.MeWsamningnumumEvr;pskaefna  #'  hags  svWiW(EES)WluWustgildihrlandi,meWreglugerWumnr.476/1994og646/1994, #( tilskipanirEvr;pusambandsinsnr.90/385,umvirk,grWanleglkningatki,ognr.93/42, $ ) umlkningatki.XarerugerWarkrfurumaWlkningatkisupr;fuWogsamrmismatfari v%N!* framWurentkinerumarkaWssett,seldeWanotuWaWildarrkjum.Uppfyllilkningatki A&"+ viWeigandigrunnkrfurmmerkjaYaumeWCE(CommunitEurope)merkinuogYarmeW  '", seljaYauhvarsemerinnanEES.lllkningatkisamkvmtWurnefndumtilskipunum '#- verWaaWhafaCEmerkingutilaWverasluhfinnanEES,enaWlgunartmaYaraWltandi (z$. lauk14jn1998.XriWjatilskipuninYessumflokki,Y.e.tilskipunnr.98/79,umtkitil_lf ( sUnagreiningar_,vartekininnEESsamninginnmeWkvrWunsameiginleguEESnefnd  arinnarnr.16626.n;vember1999.Allar_tilskipanirnar_ԀheyraundirhinarsvoklluWu_nU  aWferWatilskipanir_Ԁ_Evr;pusambandsins_,enYarergertrWfyrirnotkunalYj;WlegrastaWlaviW a _samrmismat_Ԁog_ryggispr;fanir_.UmfjgurraraskeiWhafasamningaviWrWurfariWfram T, milli_aWildarrkja_Ԁ_EFTA_/EESognokkurrarkjautanEvr;pska_efnahagssvWisins_Ԁumgagn  kvmaviWurkenninguvarWandi_samrmismat_,vottorWo.fl.(_Mutual_Ԁ_Recognition_Ԁ_Agree  ments_).XegarhafaveriWgerWirslkirsamningarviWstralu,NUjaSjlandogKanadaogeru   samningaviWrWurhafnarviWBandarkin,Sviss,Ungverjalandog_Tkkland_.Munusamn  X ingarnirviWstralu,NUjaSjland,KanadaogSvisstakatil_lkningatkja_ԀogerbyggtYv K #  aWllumrkjunumsflugteftirlitmeWaWreglumumpr;funog_samrmismat_Ԁsfylgt.M    reiknameWaWsamningarviWBandarkin,Ungverjalandog_Tkkland_ԀverWisamaveg.Land    lknirhefureftirlitmeWYvaWskyldumsamkvmt_tilskipununum_Ԁogsamningunumsfram   fylgthrlandi,endaerhrumeWlilegarryggiskrfurtil_lkningatkja_ԀaWrWa. wO    MeWfrumvarpinuerveriWaWsetja_srlg_Ԁum_lkningatki_ԀtilaWtryggjaryggisjklinga B  ogannarranotenda_lkningatkja_Ԁsembest.EinnigerveriWaWhrindaframkvmdfyrr    greindum_tilskipunum_Ԁ_Evr;pusambandsins_ԀogsamningumviWrkiutanEvr;pska_efnahags   svWisins_.HrerfarinsamaleiWogannarsstaWarNorWurlndumenDanmrkuvorusett {  lgum_lkningatki_Ԁ1991,SvYj;W1993ogNoregiogFinnlandi1994.Samkvmtn nF gildandilgumhefurlandlknireftirlitmeW_lkningatkjum_ԀYannigaWYauvaldiekkitj;ni. 9 ErekkiveriWaWbreytaYvhlutverkimeWfrumvarpinuheldurerveriWaWsetjaskUrariog  tarlegrikvWiumhvernigslkueftirlitiskulihttaW.EnnfremurerekkitluninaWbreyta  fyrirkomulagivarWandigreiningarog_geislalkningatki_ԀYvaWumYaugilda_srlg_Ԁhr r landi,lgum_geislavarnir_,nr.117/1985.Samkvmtlgumnr.155/1996,um_Lggildingar e= stofu_,oglgumnr.134/1995,umryggivruogopinbera_markaWsgslu_,annast_Lggild 0 ingarstofan_ԀeftirlitmeWryggivruog_raffanga_ԀmarkaWi.:vissahefurrktumYaWhvort  eftirlitstofunnartekurtil_lkningatkja_.Hefur;vissanm.a.skapastYarsem_tilskipunum_  _Evr;pusambandsins_Ԁum_lkningatki_ԀerhrundiWframkvmdmeWreglugerWsemhefurstoW i kvWum_lyfjalaga_,nr.93/1994. \4   0frumvarpinuerukvWiumhvaWaryggiskrfur_lkningatki_ԀYurfaaWuppfylla,merk ' ingarYeirra,meWferW,skrningu,notkuno.fl.MeWYverleitastviWaWtryggjaaWtkisem  erumarkaWieWanotkunhrlandivaldiekkisjklingumogWrumnotendumtj;ni.    _Tilkynningarskylda_ԀvegnaalvarlegraatvikaviWnotkun_lkningatkja_ԀhefurekkiveriW `  ngilegatryggWlgumframaWYessu.X;var_tilkynningarskylda_Ԁvegna_;happa_Ԁ_sjkra S+! stofnunum_Ԁsett_lknalg_,nr.53/1988,meWlgumnr.68/1998,umbreytingulknalgum. " EngartlurliggjaYvfyrirum_;hpp_Ԁtengdnotkun_lkningatkja_Ԁhrlandi.MeWfrum # varpinuernlgWsskyldaframleiWendur,seljendur,eigendurognotendur_lkningatkja_  $ aWtilkynnalandlkniumfrvik,gallaeWa;virkni_lkningatkis_ԀsemkynniaWvaldaeWa !W% valdiWhefurheilsutj;nieWadauWanotanda.Tilskipanir_Evr;pusambandsins_Ԁleggjajafnframt J""& Yskyldu_aWildarrkin_ԀaWtilkynna_Evr;puvsu_Ԁ(_Medical_Ԁ_Devices_Ԁ_Vigilance_ԀSystem)Yegar #' tilkynningarafYessutagiberast.XannigerleitastviWaWtryggjagWiogryggi_lkninga #( tkja_Ԁ_aWildarrkjum_ԀEESsamningsins. $ )   GerterrWfyriraWkostnaWursemfelstkvWumfrumvarpsinsverWigreiddursamkvmt v%N!* kvWumfjrlagaenfrumvarpiWgerirrWfyririnnheimtu_Yj;nustugjalds_Ԁvegna_markaWs A&"+ eftirlits_Ԁogmatsums;knumum_klnskar_Ԁpr;fanir_lkningatkjum_Ԁsamkvmtgjaldskr  '", errWherraseturaWfengnumtillgum_landlknis_._Gjaldskrin_ԀskaltakamiWafkostnaWiviW '#- Yj;nustuna. (z$. _  &  ViWsamningufrumvarpsinsvartekiWtillittilkvWalaganr.27/1999,umopinberareftir ( litsreglur.'(l  @ AthugasemdirviWeinstakargreinarfrumvarpsins. a   Um1.gr. T,     0greininnierfjallaWumgildissviWfrumvarpsins,enfrumvarpiWtekurtilframleiWslu,slu,  markaWssetningar,markaWseftirlits,viWhaldsognotkunarlkningatkja.ErYaWsamrmi  viWESBtilskipanirsemteknarhafaveriWinnEESsamninginnogsamninga0slandsviWrki   utanEvr;pskaefnahagssvWisins,sbr.almennarathugasemdirhraWframan.Ennfremur  X takalgintileftirlitsheilbrigWisyfirvaldameWlkningatkjumsamkvmtlgumnr.97/1990 K #  umheilbrigWisYj;nustu.    @ Um2.gr.     0greininnierfjallaWummarkmiWmeWfrumvarpinuenYaWeraWkomavegfyriraWnot wO  endurlkningatkjaverWifyrirtj;niafYeirravldum.MeWnotendumlkningatkjaertt B  viWYsemYurfalkningatkjumaWhaldavegnasjkd;msgreiningar,ftlunareWaskertrar    getu,YsemvinnameWlkningatkiogYsemhafaumsj;nmeWtkjunumogsjumviW   haldYeirra. {  @ Um3.gr. 9   0greininnieruskilgreindhugtkinlkningatki,framleiWandi,notandiogklnskpr;fun  ogeruskilgreiningarnarbyggWarkvWumtilskipanaEvr;pusambandsinsnr.90/385,um  virk,grWanleglkningatki,nr.93/42,umlkningatki,ognr.98/79,umtkitillfsUna r greiningar.LyfteljastekkilkningatkienoftgeturveriWerfittaWskerarumhvortum e= lkningatkieWalyferaWrWa.Evr;pusambandiWhefurgefiWtleiWbeiningar(Guidelines 0 relatingtothedemarcationbetweenDirective90/385/EEConactiveimplantablemedical  devices,Directive93/42/EEConmedicaldevicesandDirective65/65/EECrelatingtomedi  cinalproductsandrelateddirectives)tilaWauWveldaflokkunYessa.EfvafileikurYvhvort i tkislkningatkiskerlandlknirrumYaW.KomaleiWbeiningarEvr;pusambandsins \4 tilskoWunarYegarskeraYarfrumhvortumlkningatkieWalyferaWrWa. ' @ Um4.gr.    kvWigreinarinnarbyggjast2.,3.,5.,9.og10.gr.tilskipunarEvr;pusambandsinsnr. `  90/385,umvirk,grWanleglkningatki,2.,3.,5.,9.,11.,12.,13.,14(b)og15.gr.tilskip S+! unarEvr;pusambandsinsnr.93/42,umlkningatki,og2.,3.,5.,9.,13.,og14.gr.tilskip " unarEvr;pusambandsinsnr.98/79,umtkitillfsUnagreiningar. #   XrmeginkrfursemgerWarerutillkningatkjaerusamrmiviWkvWiI.viWauka  $ WurnefndraESBtilskipanaumlkningatki.Samsetning,framleiWsla,pkkunogviWhald !W% tkjannaskalveraYannigaWtkiWvirkieinsogleiWbeiningarframleiWandansgerarWfyrir J""& ogaWYaustofniekkiryggieWalfisjklingaeWaannarranotendahttu.Notkunmargra #' lkningatkjafylgirvisshttaY;ttfyllstaryggissgtt;hnverWurY;valltaWvera #( sttanlegmeWtillititilYeirraverkanasemtkineigaaWhafa.NauWsynlegtgeturveriWaW $ ) geramismunandikrfurtiltkjaogferYaWm.a.eftirYvnotkunarsviWisemframleiWandinn v%N!* gefurupp.SemdmimnefnaaWgeraverWurmeiriryggiskrfurtiltkjasemsjklingur A&"+ aWnotasjlfurentiltkjasemeingnguerunotuWaffaglrWustarfsf;lki.Skv.2.mgr.er  '", ;heimiltaWsetjamarkaWtkisemgeturstofnaWryggisjklingaognotendahttu.03. '#- mgr.ergertrWfyrirYvaWsmuryggiskrfursugerWartillkningatkjasemhnnuWeru (z$. ogframleiddinnanheilbrigWisstofnanaogtilannarralkningatkja.HeilbrigWisstofnanir ( hafasjlfareinhverjummlihannaWogframleitttkisemnotuWerustofnunumogverWur  aWteljaeWlilegtaWsmuryggiskrfurgildiumYessitkiognnurtki.  @ Um5.gr. T,   kvWiWfjallarummerkingarlkningatkjumogbyggist12.gr.tilskipunarEvr;pu  sambandsinsnr.90/385,umvirk,grWanleglkningatki,17.gr.tilskipunarEvr;pusam  bandsinsnr.93/42,umlkningatki,og16.gr.tilskipunarEvr;pusambandsinsnr.98/79,   umtkitillfsUnagreiningar.EinnigbyggistkvWiWtilskipun93/68umCEsamrmis  X merki.SWastnefndatilskipuninleggurYskyldurkinaWYauhafieftirlitmeWYvaWCE K #  merkinginssamrmiviWsettarreglurogekkisumvillandimerkingaraWrWa.CEsam    rmismerkiWerviWskiptalegseWlisogsUniraWtiltekinvaraersamrmiviWtilskipanirog    staWla.TilgangurYesserYvfyrstogfremstsaWauWveldamarkaWssetninguinnanEES.Ef   lkningatkierrttilegaCEmerkterekkiunntaWkomavegfyrirsluYessEvr;pska wO  efnahagssvWinu.0slendingarhafaeinniggertsamningaviWrkiutanEvr;pskaefnahags B  svWisins,t.d.stralu,NUjaSjlandogKanada,umgagnkvmaviWurkenninguvarWandi    samrmismat,vottorWo.fl.SamningarYessirgerarWfyriraWsamningsaWilarheimilimark   aWssetningulkningatkjumsemuppfyllatilteknarryggiskrfurogstaWlaoghafamerki {  semgefaYaWtilkynna.2.mgr.veitirlandlkniheimildtilaWtakalkningatkiafmarkaWi nF YrttfyriraWYaWsrttilegamerkteflj;skemuraWtkiWhefurhttulegaeiginleika.Er 9 kvWiYettasamrmiviWESBtilskipanirenheimilteraWbeitasvoklluWuryggiskvWi  eflj;skemuraWvaraerbeinlnishttuleg.TaliWermikilvgtaWheimildYessislgun  um.03.mgr.erkveWiWumundantekningarfrmerkingumogerYaWsamrmiviW4.gr. r framangreindraESBtilskipana. e= @ Um6.gr.    0greininniergerWkrafatilYessaWllumlkningatkjumskulifylgjanauWsynlegarupp  lUsingarumframleiWendurogleiWbeiningarumrugganotkuntkjanna.kvWiWbyggist i viWaukumIviWtilskipanirEvr;pusambandsinsnr.90/385,umvirk,_grWanleg_Ԁ_lkninga \4 tki_,nr.93/42,umlkningatki,ognr.98/79,umtkitillfsUnagreiningar.TaliWermiki ' lvgtaWlkningatkjumfylgig;WarupplUsingarsvoaWYausunotuWrttogvaldiekki  tj;ni.EnnfremurYarfaWverahgtaWrekjatkiWtilframleiWandanseflj;skemuraWtkiW  virkarekkieWaergallaWogYarfYvaWhafaupplUsingarumframleiWandanntkinu.Frum `  varpiWgerirrWfyriraWeflkningatkierutluWalmenningitilnotkunarskuli_notkunar S+! leiWbeiningar_Ԁveraslensku. " @ Um7.gr.  $   0kvWinuerskUrtkveWiWumaWeigandilkningatkisberibyrgWrttrinotkunYess !W% oghfniYeirrasemnotatkiW.EinnigbereigandaaWsjtilYessaWfrganguroggeymsla J""& sfullngjandiogaWviWhaldsogviWgerWarYj;nustussinntYannigaWrygginotendas #' tryggt.SemdmimnefnaaWgeymslaviWrangthitastiggeturhafthrifYaWhvernigtki #( virkar. $ )   A&"+ @ &  Um8.gr. (   kvWiWbyggist14.gr.og14(a)gr.tilskipunarEvr;pusambandsins'(ёԀnr.93/42,um  lkningatki,samt10.og12.gr.tilskipunarnr.98/79,umtkitillfsUnagreiningar.    LandlknirskalhaldaskryfirYaWilasemrekafyrirtkimeWaWsetur0slandiogfram a leiWalkningatkieWaerubyrgirfyrirmarkaWssetninguslkratkja.SkrningframleiW  T,  anda_lkningatkis_ԀtryggiraWhgtsaWvitahverberbyrgWtkisemermarkaWi.  _Skrn!!ingin_ԀtryggireinnigaWeftilkynnterumalvarlegatvikviWnotkunlkningatkja,galla  tkieWa;virknisunntaWkomaathugasemdumtilYessaWilasemberlgformlegabyrgW   tkinu.  X @ Um9.gr.      MarkmiWmeWklnskumpr;funumeraWsannpr;faaWviWeWlileganotkunsuskillkn    ingatkissamrmiviWgrunnkrfurogaWmeta;skilegarhliWarverkanirviWeWlilega   notkun.kvWiumgrunnkrfurYessarerutilskipunumEvr;pusambandsinssemeruhluti wO  afsamningnumumEvr;pskaefnahagssvWiW.EfframleiWandivillltaslkapr;funfarafram B  lkningatkigerirfrumvarpiWrWfyriraWhannsendiums;kntillandlknisenhannhefur    eftirlitmeWYvaWframkvmdpr;funarssamrmiviWreglurumg;Wastarfshttioglg   umrttindisjklinga.Fyrirmatslkriums;knergerterrWfyriraWframleiWandigreiWi {  gjald,sbr.12.gr.frumvarpsins.HlutverklandlknisvarWandiklnskarpr;fanirertaliW nF mikil""vgt,srstaklegaYegarumvirkgrWanleglkningatkieraWrWaeWatkisemeru 9 humhttuflokki.kvWiWbyggist10.gr.ogVI.viWaukatilskipun_Evr;pu##sam$$bands%  %ins_Ԁnr.90/385,umvirk,grWanleglkningatki,og15.gr.ogVIII.viWaukatilskipun  93/42,umlkningatki. r @ttUm10.gr. 0   kvWiWbyggist7.gr.tilskipunarEvr;pusambandsinsnr.90/385,umvirk,grWanleg  lkningatki,og8.gr.tilskipananr.93/42,umlkningatki,ognr.98/79,umtkitilsjk  d;msgreiningar,enYarerkveWiWumskyldustj;rnvaldatilaWhafaeftirlitmeWYvaWlkn i ingatkisemsettermarkaWuppfyllikrfurtilskipananna. \4   01.mgr.kemurframaWlandlknirhafieftirlitmeWryggilkningatkja.EftirlitmeW ' lkningatkjumgeturveriWmargvslegtensamkvmtfrumvarpinuerYaWtvennskonar,  annarsvegarmarkaWseftirlit,Y.e.eftirlitmeWYvaWlkningatkisemermarkaWssett  0slandiuppfylliryggiskrfurogkrfurummerkingar,oghinsvegareftirlitmeWYvaW `  viWhaldilkningatkjassinntogeftirlitmeWnotkunlkningatkja.OftgetureftirlitiW S+! veriWmjgtknilegtogerYekkifrilandlknisaWframkvmaYaW.ErgertrWfyriraW " gerWirverWisamningarumslkaYj;nustu,t.d.vriunntaWgerasamningviW_lg&&gildingar' # 'stofuna_ԀummarkaWseftirlitiWenYarerheimiluWgjaldtakaskv.12.gr.  $   02.mgr.erkveWiWnnarumheimildeftirlitsaWilatilaWframfylgjaeftirlitinu.TaliWer !W% mikil(())vgtaWhafakvWisemveitireftirlitsaWilaaWgangaWnauWsynlegumupplUsingumog J""& heimilarhonumaWtakasUnioggeraathuganirogpr;fanirsemnauWsynlegarerutaldarYv #' skyniaWvarnahttutj;niafvldumlkningatkja.UmmlsmeWferWogrttarrrWifer #( skv.IV.ogV.kaflalaganr.134/1995,umryggivruogopinberamarkaWsgslu,eftirYv $ ) semviW. v%N!* @ttUm11.gr.  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