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