MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU
By Rod Ruston -
Published 03 March 2017
This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.
Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration
Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR