Last July, the Medical Device Coordination Group endorsed this guide for establishing the minimum content of the clinical evaluation assessment report (CEAR). The CEAR  is a report used by the notified body to clearly document the conclusions of the assessment of the clinical evidence presented by the manufacturer in the clinical evaluation conducted and in its report (CER). As consequence, this document is also useful to setup or as checklist for the clinical evaluation report. In this blog post, we report the information from the MDCG 2020-13 useful to manufacturers for the setup or the improvement of their clinical evaluation report.

The clinical evidence presented by the manufacturer in the clinical evaluation report shall be based on the following principles:

  • Assess the suitability of using data from claimed equivalent devices, considering factors such as new indications and innovation. The relevance and adequacy of the data for demonstrating conformity are particularly important. For any characteristic of the device claimed as innovative by the manufacturer or for new indications, it is important that specific claims are supported by specific pre-clinical and clinical data and risk analysis.
  • Verify that the clinical evidence and the clinical evaluation are adequate and that the conclusions on the conformity to the relevant general safety and performance requirements are supported by data. These conclusions shall include considerations on the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training, and the post-market surveillance plan, and include a review of the need for, and the adequacy of, the post-market clinical follow up plan, where applicable.
  • Consider the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to follow clinical evidence updates coming from post-market surveillance and post-market clinical follow up data.

In this document, you can find an extract of the guidance that could be useful to manufacturers as checklist for their clinical evaluation report in order to meet the expected content that the notified bodies will expect.

The guidance also includes specific considerations on:

  • Clinical evaluation consultation procedure for certain class III and class IIb devices (Article 54)
  • Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10))
  • The voluntary clinical consultation on the clinical development strategy (Article 61(2))

In conclusion, the content of the CEAR proposed in this guidance is very useful for manufacturers  for the setup or the improvement of their clinical evaluation report. We propose in this post an extract of the guidance that could be used by manufacturers for this aim.

For the full details, please refer to the MDCG 2020-13.

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If you liked this blog and you are interested in some hints for the PMCF Plan, stay tuned for our next post in two weeks!

Authors: Dr. Martina Coscia, Dr. Andrea Biasiucci

Credits: the picture for this blog series has been inspired from a poster by R. Pradhan, S. Shrestha and U. Satyal entitled “Development of a digital tool for risk management, clinical evaluation and post-market surveillance of medical devices” for the 2020EuroConvergence conference.