Clinical Evaluation of Medical Devices: So much more than “just” a report
Clinical Evaluation of Medical Devices: So much more than “just” a report
9 PagesClinical Evaluation of Medical Devices: So much more than “just” a report by Angela Siebeneck, Director, Regulatory Strategy and Policy2 Overview In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting medical devices. This guideline was published and went into immediate effect without a transition period. Medical device manufacturers have struggled to understand and implement the guidance, which has some ambiguity and has left manufacturers with different interpretations. Manufacturers were still evaluating the changes from the MEDDEV when the EC o
