Unresolved issues mean that debate on the IVD (In Vitro Diagnostics) Directive will continue for some time to come
This article was originally published in Clinica
The grey areas of the In Vitro Diagnostics Directive (IVDD) will need to be resolved, probably by means of guidelines in the form of "Meddev" documents from the European Commission, according to Maurizio Suppo, principal consultant with MTC-Quintiles. However, in the meantime manufacturers should decide which private testing and certification companies they will use for CE marking under the directive and liaise with them as soon as possible on how these areas should be interpreted.
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