Clinical Evaluation Mandatory for All Medical Devices in Europe. As per the 2007 amendment in MDD 2007/47/EC related to the clinical evaluation of the Medical Device states that every medical device sold in Europe, regardless of its classification, must have a Clinical Evaluation Report in its technical file.
This means that all classes of medical devices i.e class I, II, III require a clinical evaluation.
what led to this change? In June 2002, a report by the European Commission’s Medical Device Experts Group (MDEG) concluded that most manufacturers did not possess adequate clinical evidence for their medical devices and that most notified bodies didn’t adequately verify the clinical evidence that was provided to them by manufacturers. The findings applied to all the classes of device.In addition, the MDEG cited clinical evaluations as a major area of concern. The MDEG is composed of representatives from various organizations in Europe and each member state’s competent authority. .
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