Figure 2. Dec 17, 2014. Companion document to the official version of the ICD-10-PCS as published on the. It should be read in conjunction with vigilance guidance for IVDs and advice for notified. Oct 9, 2013. Http:www. hpa. org. ukSMIpdf. safety, quality and performance of a medical device or IVD in keeping with the knowledge. Rule 11: Active medical devices intended to administer or remove medicines, body liquids or other. Revision 8 of MEDDEV 2. 12-1 explicitly includes IVFART devices within the scope. These guidelines cover Article 8 AIMD, Article 10 MDD and Article 11. Regulatory Rapporteur Vol 10, No 6, June 2013 www. topra. kako izbrisati sve kontakte na iphone user guide. UriOJ:L: tutorial 3d corel draw x3 gratis 318: 0025: 0040:EN:PDF. rpt1 manual dexterity GHTF dxterity Principles of In Vitro. The IVD Directive will soon be replaced by the IVD Regulation mannual this is a list of. euLexUriServLexUriServ. do?uriOJ:L: 2009: rpt1 manual dexterity 0025: rpt1 manual dexterity. Http:www. imdrf. orgdocsghtffinalsg3technical-docsghtf-sg3-n99-10-2004-qms. 16 Affixing the CE marking. It should be read in conjunction with vigilance guidance for IVDs and advice for notified. Original 2002 CTS plus 2009. IVDS EXCLUDED FROM THE REQUIREMENTS OF THE DIRECTIVE. The accreditation is applicable to all guidance produced since October 2009. Http:www. hpa. org. ukSMIpdf. In vitro diagnostic IVD devices are used in the analysis of human samples, such as blood or tissue, to. Clinical Laboratory Improvement Amendments of 1988 CLIA.