Clinical Evaluation Report (CER)

The Clinical Evaluation Report (CER) documents the results of the clinical evaluation of a medical device, which is a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to the device. The CER supports the assessment of conformity of the device with the general safety and performance requirements when used as intended by the manufacturer and is part of the technical documentation of the device. The CER is described in Annex XIV (Part A, Section 4) of the Medical Devices Regulation (2017/745) and guidance is provided in MEDDEV 2.7/1 revision 4.

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