direct ec european parliament council novemb amend council direct eec medic devic incorpor stabl deriv human blood human plasma european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur laid articl treati addit direct medic devic vitro diagnosi commiss propos sought amend council direct eec june medic devic order extend scope medic devic manufactur viabl tissu substanc human origin deriv tissu amend includ direct ec adopt direct aim amend direct eec includ scope devic incorpor integr part substanc deriv human blood plasma medic devic incorpor substanc deriv human tissu remain exclud scope direct essenti aim rule govern product distribut medic devic safeguard public health nation provis safeti health protect patient user person regard medic devic harmonis order guarante free movement devic intern market medic devic incorpor integr part substanc deriv human blood plasma purpos medic devic reason treat differ free circul medic devic incorpor integr part substanc deriv human blood plasma liabl act bodi action ancillari devic compli provis direct eec instrument supplement direct human blood deriv separ consid medicin product constitu mean council direct eec incorpor medic devic substanc subject check analog council direct eec eec check carri author empow implement aforesaid direct adopt direct articl direct eec amend articl amend paragraph insert quot devic incorpor integr part substanc separ consid medicin product constitu medicin product deriv human blood human plasma mean articl direct eec liabl act human bodi action ancillari devic hereinaft refer human blood deriv devic assess authoris accord direct quot paragraph point replac quot human blood blood product plasma blood cell human origin except human blood deriv quot annex amend section subparagraph ad quot devic incorpor integr part human blood deriv notifi bodi seek scientif opinion european agenc evalu medicin product emea qualiti safeti deriv take account commun provis analog provis direct eec eec us deriv part medic devic verifi take account intend purpos devic accord articl direct eec sampl batch bulk finish product human blood deriv test state laboratori laboratori design purpos member state quot section subparagraph ad quot case devic mean articl indic devic human blood deriv quot annex ii amend section indent replac quot statement indic devic incorpor integr part substanc human blood deriv refer section annex data test conduct connect requir assess safeti qualiti us substanc human blood deriv take account intend purpos devic quot section subparagraph replac subparagraph quot case devic refer annex section subparagraph notifi bodi aspect refer section consult compet bodi design member state accord direct eec take decis notifi bodi give due consider view express consult make decis convei final decis compet bodi concern case devic refer annex section subparagraph scientif opinion emea includ document devic notifi bodi give due consider opinion emea make decis notifi bodi deliv certif emea scientif opinion unfavour convei final decis emea quot section ad quot applic devic refer articl complet manufactur batch devic refer articl manufactur inform notifi bodi releas batch devic send offici certif releas batch human blood deriv devic issu state laboratori laboratori design purpos member state accord articl direct eec quot annex iii amend section sixth indent replac quot declar state devic incorpor integr part substanc human blood deriv refer section annex data test conduct connect requir assess safeti qualiti us substanc human blood deriv take account intend purpos devic quot section subparagraph replac subparagraph quot case devic refer annex section subparagraph notifi bodi aspect refer section consult compet bodi design member state accord direct eec take decis notifi bodi give due consider view express consult make decis convei final decis compet bodi concern case devic refer annex section subparagraph scientif opinion emea includ document devic notifi bodi give due consider opinion emea make decis notifi bodi deliv certif emea scientif opinion unfavour convei final decis emea quot annex iv section ad quot applic devic refer articl case section complet manufactur batch devic refer articl case verif section manufactur inform notifi bodi releas batch devic send offici certif releas batch human blood deriv devic issu state laboratori laboratori design purpos member state accord articl direct eec quot annex section ad quot applic devic refer articl complet manufactur batch devic refer articl manufactur inform notifi bodi releas batch devic send offici certif releas batch human blood deriv devic issu state laboratori laboratori design purpos member state accord articl direct eec quot annex ix part iii section subparagraph ad quot devic incorpor integr part human blood deriv class iii quot articl implement transit provis member state adopt publish law regul administr provis compli direct decemb immedi inform commiss thereof member state appli measur effect june member state adopt measur refer direct accompani refer occas offici public method make refer laid member state member state commun commiss text main provis domest law adopt field govern direct member state action ensur notifi bodi respons pursuant articl direct eec conform assess account relev inform characterist perform devic includ result test verif carri pre exist nation law regul administr provis respect devic period year entri forc direct member state accept place market devic conform rule forc territori date direct enter forc period year devic put servic articl direct enter forc date public offici journal european commun articl direct address member state brussel novemb european parliament presid fontain council presid schwarzenberg oj oj oj opinion european parliament march oj council common posit june oj european parliament decis octob oj direct amend direct ec european parliament council oj direct ec european parliament council octob vitro diagnost medic devic oj council direct eec june extend scope direct eec eec approxim provis laid law regul administr action relat proprietari medicin product lai special provis medicin product deriv human blood human plasma oj council direct eec approxim law member state relat analyt pharmaco toxicolog clinic standard protocol respect test medicin product oj direct amend commiss direct ec oj council direct eec june extend scope direct eec eec approxim provis laid law regul administr action relat proprietari medicin product lai special provis medicin product deriv human blood human plasma oj