A Clinical Evaluation Report (CER) is the document that presents and appraises the clinical evidence supporting a medical device's safety, clinical performance and claimed clinical benefit. It is a mandatory part of the technical documentation under EU MDR and is scrutinised closely by Notified Bodies, since it is where the manufacturer's claims meet the actual evidence.
Clinical evaluation is a continuous process, not a one-off report. The CER is the periodic written output of that process, updated on a defined frequency that reflects the device's risk class and the maturity of its evidence base. For higher risk or novel devices, annual updates are typical.
Under the previous directive it was common to justify a device by claiming equivalence to a marketed device and relying on its published evidence. MDR narrowed this route considerably: equivalence must now be demonstrated across technical, biological and clinical characteristics, and where the equivalent device belongs to another manufacturer, contractual access to their technical documentation is required. In practice this has forced many manufacturers to generate their own clinical data.
Notified Body findings frequently concern the same issues: search strategies that are not reproducible, literature that does not actually cover the claimed indication or population, claims in marketing material that exceed anything the evidence supports, gaps between the CER and the risk management file, and a post-market clinical follow-up plan that is generic rather than designed to answer the specific residual questions the evaluation identified.
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