Why is Clinical Evaluation so Important?

 

Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. Clinical evaluation is an essential prerequisite for risk management. It justifies the assumptions made in the risk management file, with respect to the benefits and thus the acceptance of a certain risk-benefit ratio.

If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with Medical Devices Regulation (MDR) 2017/745.  Clinical evaluation reports are an important step in the path to CE Marking. Many manufacturers struggle to comply with European CER requirements; but Emergo has the experience with CE regulations and clinical literature reviews to help you prepare a fully compliant CER.



IZielcompletes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. 4 with focus on detailing and clarity on every step of the clinical evaluation process that has been conducted by the manufacturers and evaluators.

  • ·         Frequent updates
  • ·         Demonstrate scientific accuracy
  • ·         Qualifications of evaluators
  • ·         Measurable objectives for CER
  • ·         Establishing equivalent



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