TNO takes decisive step over IVD's (in vitro diagnostic's) but it could prove risky
This article was originally published in Clinica
Executive Summary
TNO Certification of the Netherlands has become the first testing organisation to issue CE-marking certificates for higher risk products covered by the In Vitro Diagnostics Directive (IVDD). But it could be taking a risk in doing so. The European Commission directorate responsible for medical devices told Clinica that TNO has not yet been officially notified.