commiss direct ec april introduc detail specif requir laid council direct eec respect medic devic manufactur utilis tissu anim origin text eea relev commiss european commun regard treati establish european commun regard council direct eec june medic devic amend direct ec european parliament council articl thereof march franc adopt nation measur prohibit manufactur place market distribut import export medic devic manufactur materi anim origin dura mater substitut franc justifi measur uncertainti exist regard risk transmiss human anim spongiform encephalopathi medic devic fact altern form synthet materi autolog materi patient member state unilater nation measur legal base relat raw materi origin anim tissu present specif risk transmit anim spongiform encephalopathi nation measur relat gener protect public health risk transmit anim spongiform encephalopathi medic devic regard sourc materi medic devic provis set regul ec european parliament council octob lai health rule anim product intend human consumpt appli order improv level safeti health protect reinforc protect measur risk transmit anim spongiform encephalopathi medic devic scientif committe medicin product medic devic adopt opinion transmiss spongiform encephalopathi tse risk materi manufactur implant medic devic recommend manufactur devic utilis anim tissu deriv requir essenti part risk manag fulli justifi tissu context benefit patient comparison altern materi scientif steer committe adopt opinion risk materi product deriv rumin tissu gelatin collagen direct relev safeti medic devic medic devic manufactur utilis viabl anim tissu deriv render viabl class iii devic accord classif rule set annex ix direct eec devic intend contact intact skin prior market medic devic origin commun import countri subject conform assess procedur laid direct eec annex direct eec set essenti requir medic devic meet pursuant direct point annex set specif requir intend elimin reduc risk infect patient user parti due tissu anim origin specifi solut adopt manufactur design construct devic conform safeti principl take account gener acknowledg state art regard medic devic manufactur utilis tissu anim origin adopt detail specif relat requir point annex direct eec aspect relat risk analysi risk manag framework conform assess procedur refer articl direct term direct eec clarifi order ensur uniform implement direct provid adequ transit period medic devic cover ec design examin certif ec type examin certif measur provid direct accord opinion committe medic devic set articl council direct eec adopt direct articl direct lai detail specif relat risk transmit transmiss spongiform encephalophathi tse normal condit patient medic devic manufactur utilis anim tissu render viabl viabl product deriv anim tissu anim tissu cover direct origin bovin ovin caprin speci deer elk mink cat collagen gelatin tallow manufactur medic devic meet requir fit human consumpt direct appli medic devic refer paragraph intend contact human bodi intend contact intact skin articl purpos direct definit appli addit definit set direct eec quot cell quot mean smallest organis unit live form capabl independ exist replac substanc suitabl environ quot tissu quot mean organis cell extra cellular constitu quot deriv quot mean materi obtain anim tissu manufactur process collagen gelatin monoclon antibodi quot viabl quot mean potenti metabol multipl quot transmiss agent quot mean unclassifi pathogen entiti prion entiti bovin spongiform encephalophathi agent scrapi agent quot reduct elimin remov quot mean process number transmiss agent reduc elimin remov order prevent infect pathogen reaction quot inactiv quot mean process abil infect pathogen reaction transmiss agent reduc quot sourc countri quot mean countri anim born rear slaughter quot start materi quot mean raw materi product anim origin devic refer articl produc articl lodg applic conform assess pursuant articl direct eec manufactur medic devic refer articl carri risk analysi risk manag scheme set annex direct articl member state verifi bodi notifi articl direct eec date knowledg medic devic refer articl order assess conform devic refer articl provis direct eec specif laid annex direct basi verif member state amend task notifi bodi member state notifi commiss member state articl conform assess procedur medic devic refer articl includ evalu complianc essenti requir direct eec specif laid annex direct notifi bodi evalu manufactur risk analysi risk manag strategi inform provid manufactur justif anim tissu deriv result elimin inactiv studi literatur search manufactur control sourc raw materi finish product subcontractor audit matter relat sourc includ parti suppli notifi bodi evalu risk analysi risk manag framework conform assess procedur account tse certif suitabl issu european director qualiti medicin hereinaft quot tse certif quot start materi medic devic start materi tse certif issu refer paragraph nation bodi compet author seek opinion compet author member state evalu conclus risk analysi risk manag tissu deriv intend incorpor medic devic establish manufactur issu ec design examin certif ec type examin certif notifi bodi give due consider comment receiv week date opinion nation compet author sought articl member state step ensur medic devic refer articl market put servic compli provis direct eec specif laid annex direct articl holder ec design examin certif ec type examin certif issu april medic devic refer articl appli complementari ec design examin certif ec type examin certif attest complianc specif laid annex direct septemb member state accept place market put servic medic devic refer articl cover ec design examin certif ec type examin certif issu april articl member state adopt publish januari provis compli direct forthwith inform commiss thereof appli provis effect april member state adopt provis refer direct accompani refer time offici public member state determin refer made 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 april commiss erkki liikanen member commiss oj oj oj oj annex risk analysi risk manag justif anim tissu deriv manufactur justifi basi risk analysi risk manag strategi specif medic devic decis anim tissu deriv refer articl anim speci tissu take account expect clinic benefit potenti residu risk suitabl altern assess procedur order ensur high level protect patient user manufactur devic utilis anim tissu deriv refer point implement document risk analysi risk manag strategi address relev relat aspect tse identifi hazard tissu deriv establish document measur minimis risk transmiss demonstr accept residu risk devic utilis tissu deriv take account intend benefit devic safeti devic term potenti pass transmiss agent depend factor point analys evalu manag measur combin determin devic safeti kei step consid select start materi tissu deriv consid potenti contamin transmiss agent take account process appli product process remov inactiv transmiss agent control sourc tissu deriv characterist devic intend account perform risk analysi risk manag strategi due consider opinion adopt relev scientif committe opinion committe proprietari medicin product cpmp refer publish offici journal european union anim sourc materi tse risk relat sourc speci strain natur start tissu accumul tse infect occur incub period year sourc young healthi anim consid factor reduc risk risk anim fallen stock emerg slaughter tse suspect anim exclud geograph sourc pend classif countri bse statu regul ec european parliament council lai rule prevent control erad transmiss spongiform encephalopathi geograph bse risk gbr assess risk sourc countri gbr qualit indic likelihood presenc cattl infect bse pre clinic clinic point time countri presenc confirm gbr indic level infect tabl gt tabl gt factor influenc geograph risk bse infect raw tissu deriv individu countri factor defin articl point intern anim health code oie offic intern de épizooti web site www oie int eng norm mcode htm scientif steer committe made assess geograph bse risk gbr countri member state continu countri appli bse statu categoris take main oie factor account natur start tissu manufactur account classif hazard relat type start tissu sourc anim tissu subject control individu inspect veterinarian anim carcass certifi fit human consumpt manufactur ensur risk cross contamin occur time slaughter manufactur sourc anim tissu deriv classifi potenti high tse infect sourc materi except circumst take account import benefit patient absenc altern start tissu addit provis regul ec european parliament council octob lai health rule anim product intend human consumpt appli sheep goat classif infect tissu sheep goat establish base actual knowledg basi titr transmiss agent tissu bodi fluid natur infect sheep goat clinic scrapi tabl present scientif steer committe ssc opinion juli quot polici breed genotyp sheep quot annex updat opinion ssc tse infect distribut rumin tissu state knowledg decemb adopt januari classif review light scientif evid relev opinion scientif committe committe proprietari medicin product cpmp commiss measur regul materi present risk tse review refer relev document opinion publish offici journal european union list commiss decis cattl list risk materi srm laid regul ec consid potenti high tse infect inactiv remov transmiss agent devic withstand inactiv elimin process undergo unaccept degrad manufactur reli princip control sourc devic claim made manufactur abil manufactur process remov inactiv transmiss agent substanti document relev inform scientif literatur search analysi support inactiv elimin factor specif process refer literatur compar devic search analysi cover scientif opinion adopt eu scientif committe opinion serv refer case conflict opinion literatur search fail substanti claim manufactur set specif inactiv elimin studi scientif basi consid identifi hazard tissu identif relev model agent rational choic combin model agent identif stage chosen elimin inactiv transmiss agent calcul reduct factor final report identifi manufactur paramet limit critic effect inactiv elimin process document procedur appli ensur valid process paramet appli routin manufactur quantiti anim start tissu deriv requir produc unit medic devic manufactur evalu quantiti raw tissu deriv anim origin requir produc singl unit medic devic purif process involv manufactur assess potenti concentr level transmiss agent present anim start tissu deriv tissu deriv anim origin come contact patient user manufactur quantiti anim tissu deriv ii contact area surfac type skin mucou tissu brain condit healthi damag iii type tissu deriv come contact patient user iv long devic intend remain contact bodi includ bioresorpt effect number medic devic procedur account rout administr manufactur account rout administr recommend product inform highest risk lowest review assess manufactur establish maintain systemat procedur review inform gain medic devic similar devic post product phase inform evalu relev safeti previous unrecognis hazard detect estim risk aris hazard longer accept origin assess invalid appli result evalu fed back input risk manag process light inform review risk manag measur devic consid includ rational choos anim tissu deriv potenti residu risk accept chang impact previous implement risk control measur evalu justifi result evalu document evalu class iii medic devic notifi bodi devic fall class iii rule annex ix direct eec manufactur provid notifi bodi refer articl direct relev inform evalu current risk analysi risk manag strategi inform tse risk collect manufactur relev devic notifi bodi inform chang relat process sourc collect handl inactiv elimin modifi result manufactur risk manag dossier transmit notifi bodi purpos addit approv prior implement oj websit commiss http europa eu int comm food fs sc ssc outcom en html websit commiss http europa eu int comm food fs sc ssc outcom en html medic devic utilis anim tissu deriv render viabl devic intend contact intact skin