Summary of the main points of MDCG 2020-13

MDCGroup has published one of the most anticipated documents for the industry, namely the Clinical Evaluation Assessment Report (CEAR). Access the MDCSg 2020-13 document here
We have summarized the main points of interest for Manufacturers !

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Take-home messages:
1. A CEAR IS NOT A CER TEMPLATE
2. At the end of the day, a CER is about two things:
a) to be able to state that by COMBINING and analyzing clinical evidence coming out of literature, internal PMS, external vigilance data, risk management data (including residual risk report) it was shown that the device’s IFU either remains accurate or has undergone a revision
b) to provide evidence that ALL risks that could have a significant impact in the benefit-risk analysis have been identified in the clinical evaluation AND have been aligned with risk management, i.e. all risks have been cross-checked with the literature and have been mitigated down to the point where it can be stated that the benefit/risk profile for the device in scope has an acceptable risk level when weighed against the benefits to the patient

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