Differing national interpretations of the IVD (in vitro diagnostic) Directive will test manufacturers' ability to comply
This article was originally published in Clinica
Executive Summary
The Medical Devices Directive was supposed to create a single European regulatory environment for such products throughout the European Economic Area. But differences in the way individual health authorities have transposed it mean that in practice requirements for manufacturers can vary considerably from country to country. The same will be true of the In Vitro Diagnostics Directive, which has technically just come into force. Maureen Kenny reports.