EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament
By Michael Mezher -
Published 07 March 2017
The EU's new rules governing medical device and in vitro diagnostics (IVDs) are one step away from being fully adopted.
Categories: News, Europe, In vitro diagnostics, Medical Devices
Tags: Medical Device Regulations, MDR, In Vitro Diagnostics Regulations, IVDR, EU Council
IMDRF Offers a Preview of Next Week’s Vancouver Meeting
By Zachary Brennan -
Published 06 March 2017
Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.
Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration
Tags: IMDRF, MDR, IVDR, MDUFA, Cures
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