<h1 class="entry-title">Category: Clinical Evaluation Reports</h1>

EU MDR Clinical Evaluation Report (CER) Frequency

February 21, 2023 EU MDR Clinical Evaluation Report (CER) Frequency   The EU MDR doesn’t prescribe the frequency at which CERs are to be updated.  Modeling this, the MDCG (2020-13) has left manufacturers the liberty to, “…Identify when updates to the clinical evaluation report shall be assessed during the surveillance and post certification monitoring activities and […]