CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation

Posted 01 December 2017 By Jonathan Bray, PhD, Michelle O'Connor, PhD, Robert D. Cumming

placeholder+image 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.

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Categories: In vitro diagnostics, Medical Devices, Clinical, Submission and registration, Features, Europe, EC

Tags: MDR, IVDR, CE Marking

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