Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports

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Winning Device EU Marketing Approval
Seven Steps to Writing Clinical Evaluation Reports

You want to market your device in Europe, but your development phase didn’t include clinical trials. You can submit a clinical evaluation report (CER) that includes data from the development of similar approved devices.

It involves weeks of literature review, market research and clinical data analysis. And, that’s before you even start writing. How you put the information together can make all the difference in your application.

A well-crafted CER can pay off in a marketing authorization certificate.

This FDAnews Brief takes you through the process of developing and writing a CER with a 7-point model that ensures you cover all the bases and have the greatest chance of success. You’ll learn how to put together these elements of a strong CER:

  1. Administrative information
  2. State of the art overview
  3. Equivalence evidence
  4. Context and choice of clinical data
  5. Summary of clinical data
  6. Data analysis
  7. Conclusion and supporting resources

Winning Device EU Marketing Approval provides practical lessons and advice — actionable information — you can use to apply for your CE Mark designation.


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