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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- 61By Robert Zott, Sr. Regulatory Analyst Originally Published: November 14, 2017 The publication of the new Medical Device Regulation (MDR) 2017/745 in the European Journal, with its entry into force on May 25, 2017, marks the end of an eight-year period of controversy, and the beginning of a three-year transition to the most sweeping regulatory…
- 59When it comes to the new European Medical Device Regulation (MDR), it’s critical to know where you stand. Take a look at the MDR timeline here.
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