SFS 2011:805 Lag om ändring i lagen (1993:584) om medicintekniska produkter

<div><style type="text/css"> <!-- p {margin: 0; padding: 0;} .ft10{font-size:14px;font-family:TimesNewRoman;color:#000000;} .ft11{font-size:27px;font-family:TimesNewRoman,Bold;color:#000000;} .ft12{font-size:19px;font-family:TimesNewRoman,Bold;color:#000000;} .ft13{font-size:8px;font-family:TimesNewRoman;color:#000000;} .ft14{font-size:14px;font-family:TimesNewRoman,Bold;color:#000000;} .ft15{font-size:7px;font-family:TimesNewRoman;color:#000000;} .ft16{font-size:12px;font-family:TimesNewRoman;color:#000000;} .ft17{font-size:17px;font-family:TimesNewRoman,Bold;color:#000000;} .ft18{font-size:19px;line-height:19px;font-family:TimesNewRoman,Bold;color:#000000;} .ft19{font-size:14px;line-height:17px;font-family:TimesNewRoman;color:#000000;} .ft110{font-size:12px;line-height:15px;font-family:TimesNewRoman;color:#000000;} --> <!-- p {margin: 0; padding: 0;} .ft20{font-size:8px;font-family:TimesNewRoman;color:#000000;} --> </style> <div id="page1-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1039px;left:741px;white-space:nowrap" class="ft10">1</p> <p style="position:absolute;top:197px;left:172px;white-space:nowrap" class="ft11"><b>Svensk f�rfattningssamling</b></p> <p style="position:absolute;top:309px;left:172px;white-space:nowrap" class="ft18"><b>Lag<br/>om �ndring i lagen (1993:584) om medicintekniska <br/>produkter;</b></p> <p style="position:absolute;top:385px;left:172px;white-space:nowrap" class="ft10">utf�rdad den 16 juni 2011.</p> <p style="position:absolute;top:420px;left:187px;white-space:nowrap" class="ft10">Enligt riksdagens beslut</p> <p style="position:absolute;top:418px;left:327px;white-space:nowrap" class="ft13">1 f�reskrivs att 7 och 10 �� lagen (1993:584) om</p> <p style="position:absolute;top:438px;left:172px;white-space:nowrap" class="ft10">medicintekniska produkter ska ha f�ljande lydelse.</p> <p style="position:absolute;top:473px;left:172px;white-space:nowrap" class="ft14"><b>7 �</b></p> <p style="position:absolute;top:471px;left:190px;white-space:nowrap" class="ft13">2</p> <p style="position:absolute;top:473px;left:209px;white-space:nowrap" class="ft10">Den myndighet som regeringen best�mmer ska avg�ra till vilken</p> <p style="position:absolute;top:491px;left:172px;white-space:nowrap" class="ft19">produktklass en medicinteknisk produkt ska f�ras om det uppst�r en tvist<br/>som r�r till�mpningen av klassificeringsreglerna mellan en tillverkare och<br/>ett s�dant organ som ska anm�las enligt 79 �� lagen (2011:791) om<br/>ackreditering och teknisk kontroll.</p> <p style="position:absolute;top:579px;left:172px;white-space:nowrap" class="ft14"><b>10 �</b></p> <p style="position:absolute;top:577px;left:197px;white-space:nowrap" class="ft13">3</p> <p style="position:absolute;top:579px;left:216px;white-space:nowrap" class="ft10">Regeringen, eller den myndighet som regeringen best�mmer, f�r</p> <p style="position:absolute;top:596px;left:172px;white-space:nowrap" class="ft10">meddela f�reskrifter om skyldighet f�r </p> <p style="position:absolute;top:614px;left:187px;white-space:nowrap" class="ft10">1. en tillverkare av medicintekniska produkter eller en tillverkares ombud</p> <p style="position:absolute;top:632px;left:172px;white-space:nowrap" class="ft19">i Sverige att l�mna uppgifter till en myndighet om sin verksamhet och sina<br/>produkter,</p> <p style="position:absolute;top:667px;left:187px;white-space:nowrap" class="ft10">2. s�dana organ som ska anm�las enligt 79 �� lagen (2011:791) om ack-</p> <p style="position:absolute;top:685px;left:172px;white-space:nowrap" class="ft19">reditering och teknisk kontroll (anm�lda organ) att l�mna uppgifter till en<br/>myndighet om certifikat som utf�rdats, �ndrats, kompletterats, tillf�lligt eller<br/>slutgiltigt �terkallats, och</p> <p style="position:absolute;top:738px;left:187px;white-space:nowrap" class="ft10">3. anm�lda organ att l�mna uppgifter till en myndighet om certifikat som</p> <p style="position:absolute;top:755px;left:172px;white-space:nowrap" class="ft10">v�grats.</p> <p style="position:absolute;top:792px;left:187px;white-space:nowrap" class="ft10">Denna lag tr�der i kraft den 1 augusti 2011.</p> <p style="position:absolute;top:827px;left:172px;white-space:nowrap" class="ft10">P� regeringens v�gnar</p> <p style="position:absolute;top:862px;left:172px;white-space:nowrap" class="ft10">G�RAN H�GGLUND</p> <p style="position:absolute;top:880px;left:403px;white-space:nowrap" class="ft19">Kjell Rempler<br/>(Socialdepartementet) </p> <p style="position:absolute;top:1011px;left:172px;white-space:nowrap" class="ft15">1 Prop. 2010/11:80, bet. 2010/11:NU25, rskr. 2010/11:272.</p> <p style="position:absolute;top:1023px;left:172px;white-space:nowrap" class="ft15">2 Senaste lydelse 1997:1236.</p> <p style="position:absolute;top:1036px;left:172px;white-space:nowrap" class="ft15">3 Senaste lydelse 2009:271.</p> <p style="position:absolute;top:292px;left:634px;white-space:nowrap" class="ft17"><b>SFS 2011:805</b></p> <p style="position:absolute;top:318px;left:634px;white-space:nowrap" class="ft110">Utkom fr�n trycket<br/>den 27 juni 2011</p> </div> <div id="page2-div" style="position:relative;width:892px;height:1263px;"> <img width="892" height="1263" src="/Static/i/lagboken/hidden.png" alt="background image"/> <p style="position:absolute;top:1059px;left:539px;white-space:nowrap" class="ft20">Thomson Reuters Professional AB, tel. 08-587 671 00</p> <p style="position:absolute;top:1069px;left:609px;white-space:nowrap" class="ft20">Edita V�stra Aros, V�ster�s 2011</p> </div> </div> ;