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Medical, European Union CE Marking of In Vitro Diagnostic Medical Devices in the European Union - December 2011 Market Research Report Code: 75751112 Price: $80.00 Instant Online Delivery (Add any three reports to your basket and the report with the lowest price is free) FREE! Table of Contents in PDF format with Page Numbers Table of Contents Summary Introduction What is the CE mark? Who has to comply with the Directive? EU Definition of an In Vitro Diagnostic Medical Device Steps towards CE marking Classification Essential Requirements, Risk Analysis and Use of Standards Conformity Assessment and Notified Body Involvement Marking and Labeling Vigilance System Declaration of Conformity and Authorized Representative Registration Review of the EU Regulatory Framework for IVDs Useful Websites Related Reports: Report Title Price Medical Device Legislation in the EU - October 2006 $65.00 Medical Device Legislation in the European Union - August 2010 $105.00

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