CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation
By Jonathan Bray, PhD, Michelle O'Connor, PhD, Robert D. Cumming -
Published 01 December 2017
This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system.1 The regulations, intended to affect greater IVD safety and reliability, expand the definition of an IVD to include software used as any part of an IVD, as well as an IVD used for providing information concerning the predisposition to a medical condition or disease. An IVD also may be a device used to predict a treatment response or reaction to a treatment. Moving forward, all Class B through Class D IVDs will require some level of conformity assessment by an independent Notified Body.
Categories: Features, Europe, EC, Clinical, In vitro diagnostics, Medical Devices, Submission and registration
Tags: MDR, IVDR, CE Marking
What to do if a Device Manufacturer’s Notified Body Halts Operations? France’s ANSM Explains
By Zachary Brennan -
Published 14 November 2016
For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority.
Categories: News, Europe, EC, Business and Leadership, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration
Tags: ANSM, CE marking, notified bodies
Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking
By Stewart Eisenhart, Emergo Group -
Published 22 October 2014
The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies.
Categories: News, Oceania, TGA, In vitro diagnostics, Medical Devices, Submission and registration
Tags: CE Marking, Tony Abbott