By Stewart Eisenhart, Emergo Group
A voluntary code of conduct for European Notified Bodies appears to be gaining traction following the document’s publishing in early 2011.
Medtechinsider.com reports that eleven Notified Bodies have now signed the code of conduct ahead of a highly anticipated recast of the European Medical Devices Directive.
As we reported last May, the “NB5”—Notified Bodies BSI, TÜV Rheinland, TÜV SÜD, LNE-GMED and DEKRA/KEMA—plan on issuing a second draft of the code of conduct next month to address issues such as the IVD Directive and Conformity Assessments stipulated by MDD Annex III and AIMD Annex 3 (Type Examination) that are not included in the current iteration of the document. (These issues were not addressed in the first version of the code of conduct.)
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.