January 19, 2024 U.S. FDA 510(k) Clinical Data Requirements I always reminded clients that clinical data may not be required at all for a 510(k) subject device even though clinical data may have been required for the predicate. A pre-sub(s) is generally a good idea and in all parties’ best interest for unusual […]
<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 […]