commiss direct ec februari reclassif breast implant framework direct eec medic devic 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 regard request submit franc unit kingdom basi classif criteria set annex ix direct eec breast implant princip class iib medic devic franc unit kingdom request classif breast implant class iii medic devic derog provis annex ix direct eec order ensur highest level safeti breast implant notifi bodi full qualiti assur system carri examin design dossier product accord point annex ii direct eec proce reclassif breast implant class iii medic devic determin regim applic breast implant market septemb articl iii 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 amend direct eec adopt direct articl derog rule set annex ix direct eec breast implant reclassifi medic devic fall class iii articl breast implant market septemb pursuant articl iii direct eec subject conform reassess procedur class iii medic devic march derog articl direct eec decis breast implant notifi bodi septemb articl direct eec extend articl member state adopt publish law regul administr provis compli direct august immedi inform commiss thereof member state adopt provis refer direct accompani refer time offici public procedur refer adopt member state member state appli measur effect septemb member state commun commiss text provis nation law adopt field cover direct articl direct address member state brussel februari commiss erkki liikanen member commiss oj oj oj oj