By Donna Mitchell-Magaldi, Nerac Analyst,
On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev 3 is the evaluation of the clinical literature (European Commission, 2009). The literature search is used to identify clinical data that is outside the manufacturer’s possession and can be used to assist in the evaluation of the device in question. The literature can address the specific product or an equivalent device (MedDev 2.7.1 Rev 3).
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