Search Results for MDR

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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

FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically By Alexander Gaffney, RAC - Published 19 June 2015

The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically.

Categories: News, US, CDRH, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: eMDR, MDR, Adverse Events, 3500A, Final Rule, Medical Device Reporting

New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes By Alexander Gaffney, RAC - Published 20 August 2014

US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Labeling, Medical Devices

Tags: openFDA, MAUDE, SPL, Drug Labels, MDR, Medical Device Adverse Event, AE

In Unusual One-Two Punch, FDA Follows 'Extensive' Warning Letter With Safety Communication By Alexander Gaffney, RAC - Published 30 April 2014

Categories: US, FDA

Tags: MDR, Contracting, Outsourcing, QSR, Park Doctrine, warning letter, Latest News, medical device