MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical Device Regulation (MDR) 2017/745. Transitioning directly from MEDDEV 2.7/1 revision 3 to the MDR would have been a huge leap; revision 4 has provided a stepping stone along the way to the MDR. This article considers how clinical evaluation and clinical evaluation reports (CERs) have evolved since 2016 and why MEDDEV 2.7/1 revision 4 is still in use today.
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