commiss direct ec august reclassif hip knee shoulder joint replac framework council direct eec medic devic text eea relev commiss european commun regard treati establish european commun regard council direct eec june medic devic articl thereof regard request submit franc unit kingdom basi classif rule set annex ix direct eec total joint replac class iib medic devic franc unit kingdom request classif total joint replac class iii medic devic derog provis annex ix direct eec order ensur conform assess total joint replac place market conform assess base number element proper classif design monitor notifi bodi proper implement conform assess modul direct eec reclassif derog classif rule set annex ix direct eec shortcom identifi due specif characterist product properli address conform assess procedur categori hip knee shoulder replac distinguish total joint replac due complex joint function restor consequ increas risk failur due devic hip knee replac weight bear extrem sophist implant risk revis surgeri significantli greater joint shoulder implant recent techniqu subject similar dynam forc replac principl connect medic problem hip knee shoulder replac surgeri increasingli take place young peopl high life expect implant function properli life expect patient reduc revis surgeri risk increas specif clinic data includ long term perform data hip knee shoulder replac market put servic conclus clinic data collect manufactur framework evalu conform product requir characterist perform refer section annex direct eec subject attent examin order verifi appropri clinic data total joint replac subject multipl modif introduct clinic place market shown hip knee replac market experi shown sight minor post market design previous troubl free replac lead problem due unintend consequ lead earli failur major safeti concern order achiev optim level safeti health protect reduc design relat problem lowest level design dossier hip knee shoulder replac includ clinic data manufactur support claim perform subsequ post market design manufactur examin detail notifi bodi devic introduc gener clinic notifi bodi full qualiti assur system effect carri examin design dossier approv design accord point annex ii direct eec reason proce reclassif hip knee shoulder total joint replac class iii medic devic provid adequ transit period hip knee shoulder total joint replac assess class iib medic devic full qualiti assur system annex ii direct eec allow complementari assess point annex ii direct hip knee shoulder total joint replac certifi procedur relat ec type examin set annex iii direct eec coupl procedur relat ec verif set annex iv procedur relat ec declar conform set annex direct affect present direct certif scheme class iib class iii medic devic provid adequ transit period hip knee shoulder total joint replac subject procedur relat ec type examin annex iii direct eec coupl procedur relat ec declar conform set annex vi direct allow assess annex iv annex direct eec measur provid direct accord opinion committe medic devic set articl council direct eec june approxim law member state relat activ implant medic devic adopt direct articl derog rule set annex ix direct eec hip knee shoulder replac reclassifi medic devic fall class iii articl purpos direct hip knee shoulder replac mean implant compon part total joint replac system intend provid function similar natur hip joint natur knee joint natur shoulder joint ancillari compon screw wedg plate instrument exclud definit articl hip knee shoulder replac subject conform assess procedur pursuant articl direct eec septemb subject complementari conform assess point annex ii direct eec lead ec design examin certif septemb provis preclud manufactur submit applic conform assess base articl direct eec hip knee shoulder replac subject conform assess procedur pursuant articl iii direct eec septemb subject conform assess class iii medic devic pursuant articl ii septemb provis preclud manufactur submit applic conform assess base articl direct eec member state accept septemb place market put servic hip knee shoulder replac cover decis accord articl direct eec issu septemb member state accept septemb place market hip knee shoulder replac cover decis accord articl iii direct eec issu septemb permit total joint replac put servic date articl member state adopt publish law regul administr provis compli direct march immedi inform commiss thereof member state adopt provis refer direct accompani refer time offici public member state determin refer made member state appli provis septemb member state commun commiss text provis nation law adopt field cover direct articl direct enter forc dai public offici journal european union articl direct address member state brussel august commiss günter verheugen vice presid oj direct amend regul ec european parliament council oj oj direct amend regul ec european parliament council