Clinical Evaluation - MEDDEV 2.7.1 Rev. 3 Released - December 2009

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Dear All

The European Commission has published revised version of Clinical Evaluation guidance document MEDDEV 2.7.1-Rev.3. This document has been brought more into line with the Global Harmonization Task Force (GHTF) guidance on the same subject issued in 2007. It also takes into account the revisions to the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) brought about by Directive 2007/47/EC.

Regards
S. Subramaniam
 

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  • 2_7_1rev_3_en.pdf
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