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About us
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Regulatory Texts
Regulation (EU) 2017/754
MEDDEV 2.7/1 revision 4
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News, μ-Blog / June 30, 2016
MEDDEV 2.7/1 revision 4 released
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News / February 1, 2009
2009 – NBOG-document for evaluation of technical documentations
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News / July 18, 2009
2009 – MEDDEV 2.7.1 Rev. 3
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2009 – 4th version of the Medical Devices Act
2009 – NBOG-document for evaluation of technical documentations
2008 – draft version for clinical studies by the GHTF
2008 – MEDDEV 2.7.1 Annex I
2007 – Council Directive 2007/47/EC
2007 – GHTF-documents of the Study Group 5
2006 – GHTF-document of the Study Group 5
2004 – ZLG-document for evaluation of clinical data
2003 – ISO 14155
2003 – response of the notified bodies
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