direct ec european parliament council decemb amend council direct eec medic devic text eea relev 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 direct aim includ scope direct eec medic devic incorpor integr part substanc deriv human blood human 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 adopt direct articl articl direct eec amend point replac quot medicin product cover direct eec includ medicin product deriv blood cover direct eec quot point replac quot human blood blood product plasma blood cell human origin devic incorpor time place market blood product plasma cell except devic refer paragraph quot articl implement transit provis decemb member state adopt publish law regul administr provis compli direct 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 nation law adopt field govern direct member state action ensur notifi bodi respons pursuant articl direct eec conform assess account relev inform characterist perform devic incorpor stabl deriv human blood human plasma includ result pertin test verif carri pre exist nation law regul administr provis respect devic period year entri forc direct member state accept place market devic incorpor stabl deriv human blood human plasma 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 decemb european parliament presid fontain council presid durant opinion european parliament deliv octob publish offici journal council decis decemb oj direct amend direct ec european parliament council oj