No Worries Resourced.
Here is the info.
http://www.lne-gmed.com/pdf/en/annex9-directive-93-42-amended.pdf
http://www.coe.int/t/dghl/standardsetting/medicrime/dir2001_83_cons_20081230_en.pdf
http://www.emergogroup.com/files/medical-device-regulatory-process-europe.pdf
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