commiss decis januari nation provis hiv test kit notifi articl ec treati unit kingdom direct ec vitro diagnost medic devic notifi document number text eea relev ec commiss european commun regard treati establish european commun articl thereof fact commun legisl direct ec direct ec european parliament council octob vitro diagnost medic devic lai harmonis rule safeti health protect perform characterist authoris procedur vitro diagnost medic devic view place market put servic direct ec stipul articl member state step ensur devic market put servic compli requir laid direct duli suppli properli instal maintain accord intend purpos direct ec stipul articl member state creat obstacl place market put servic territori devic bear ec mark indic consid meet requir set direct direct ec annex specif label requir relat product characterist includ instruct proper safe requir aim inform user residu risk relat product provid inform identif devic special microbiolog state storag handl condit oper instruct precaut notifi nation provis unit kingdom intend maintain forc nation provis hiv test kit provis set hiv test kit servic regul si regul appli april notif unit kingdom relat quot provis regul potenti relat free movement good quot notif provis make offenc uk sell suppli advertis sale suppli hiv test kit compon part kit member public articl regul make offenc sell suppli hiv test kit accompani time sale suppli unit kingdom notic indic suppli member public articl regul posit test reli confirm test result neg test detect recent acquir hiv articl regul unit kingdom justifi request refer protect life public health ensur qualiti hiv test servic underpin govern public health polici hiv context individu take hiv test opportun receiv pre test discuss post posit test counsel train health care profession discuss impact consequ posit hiv test dealt commun import advic prevent transmiss ii procedur direct ec european parliament council adopt octob member state adopt publish nation provis compli direct decemb appli effect june articl treati read quot adopt council commiss harmonis measur member state deem maintain nation provis ground major refer articl relat protect environ work environ notifi commiss provis ground maintain quot letter juli unit kingdom perman represent inform commiss accord articl ec treati unit kingdom intend maintain forc hiv test kit servic regul notif receiv august articl treati month period examin notif articl start august dai notif receiv iii assess notif submit unit kingdom author juli intend maintain forc nation provis adopt direct ec constitut harmonis measur adopt basi articl treati articl direct ec prohibit restrict place market put servic devic compli direct articl regul introduc restrict distribut hiv test kit limit avail medic profess direct ec rule distribut vitro diagnost medic devic place market put servic nation measur articl regul fall scope direct ec label requir direct ec relat product characterist concern proper safe storag handl condit instruct oper instruct relev inform relat product notifi nation measur requir notic indic product sold suppli member public intend give inform restrict distribut hiv test kit direct ec provis distribut vitro diagnost medic devic label requir distribut market nation measur articl regul fall scope direct ec label requir direct ec aim inform user residu risk relat product impos inform proper safe precaut includ possibl fals posit fals neg result notifi nation measur requir warn draw attent user fault posit neg result intend give inform risk relat product nation measur articl regul implement direct ec iv conclus articl ec treati aim approv reject nation measur derog harmonis measur nation provis fall scope harmonis direct intend implement direct assess procedur light consider prejudic assess commiss make compat notifi nation measur ec treati commiss opinion notif unit kingdom maintain measur hiv test kit servic regul submit juli refer articl treati inadmiss adopt decis articl notif mainten notifi measur hiv test kit servic regul unit kingdom submit commiss juli basi articl treati declar inadmiss articl decis address unit kingdom great britain northern ireland brussel januari commiss erkki liikanen member commiss oj