By Robert Zott
Originally Published: February 7, 2018
The European Union is undergoing the most sweeping regulatory changes in its history with regard to medical devices. The sheer number and scope of the changes have left manufacturers stunned and scrambling for pathways to compliance under MEDDEV Clinical Evaluation Guidance 2.7/1 Revision 4 or in anticipation of the new Medical Device Regulation (MDR). As a result, nonconformity reigns and the creation of Clinical Evaluation Reports (CERs)—the key documents used to meet the current Medical Device Directive (MDD)—is fraught with misguided approaches that might appear to meet the regulations on paper, but bear little resemblance to the real-world needs of patients.
This article explores potential pitfalls now faced by device manufacturers regarding CERs and offers guidance on how to navigate them with success. Learn more here!
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