Clinical Evaluation Report

  • The clinical examination findings of your medical device are documented in a Clinical Evaluation Report (CER). A CER comprises evaluated clinical data from either clinical research of your device or the findings of previous studies on devices that are substantially identical to yours. Pubrica has the CER certifies that your product accomplishes its goal while providing no additional danger to users or patients.
  • In Europe, all medical equipment must have Clinical Evaluation Reports. Your CER must be included in your European CE Technical File and submitted to your Notified Body. The Technical File is necessary for getting CE Marking for your product, which is required in Europe to sell or distribute medical equipment.
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  • There are three steps to a clinical assessment. Manufacturers find clinical data in step one by looking through existing literature, clinical experience, clinical trials, or any combination of the three. The data’s relevance, application, quality, and importance are all evaluated in the second stage. The final stage asks you to express your findings in the CER based on the information you gathered.
  • As part of your post-market surveillance and vigilance efforts, you must update your CER regularly. You must keep track of any significant modifications to the primary data and attach the CER appropriately. Failure to do so might put your compliance with the Medical Devices Directive at risk.
  • Clinical Study Reports will be subject to stricter criteria under Europe’s new Medical Device Regulation (MDR), including the rationale for demonstrating equivalence with another device and the quality of data used in your clinical evaluation.

References

Kau, Chung How, Jennifer T. Nguyen, and J. D. English. “The clinical evaluation of a novel cyclical force generating device in orthodontics.” Orthodontic Practice US 1.1 (2010): 10-15.