Choosing an IVD notified body: start now and gain a competitive edge.
Following more than two years of negotiation, the In Vitro Diagnostic Directive could be nearing adoption by Member States. Manufacturers will then have a short window of opportunity to obtain the CE mark early in the transition period when it has real competitive value. This article recommends immediate action and looks at some of the issues to consider when choosing a Notified Body.
Suppo
M
M
MTC, Turin, Italy. msuppo@icip.com
D004282:Documentation; D017277:Drug Approval; D004465:Economic Competition; D005060:Europe; D007202:Indicators and Reagents / Q000592:standards*; D008389:Marketing of Health Services; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*
D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic