Portfolio expansion – Clinical Study Templates now also offers Post-Market Clinical Follow-up Plan (PMCFP) and Post-Market Clinical Follow-up Report (PMCFR) templates as part of the clinical evaluation process required to place and/or retain Class I-III medical devices on the EU market. These templates are designed to strategize and document post-market clinical data collection in support of the clinical evaluation of a medical device on the EU market. These templates are fully compliant with the EU MDR 2017/745 required content and section order, as recommended per the MDCG 2020-7 and 2020-8 guidelines.
The new templates are a valuable addition to the existing portfolio of Clinical Evaluation Report (CER) and Clinical Evaluation Plan (CEP) templates that are compliant with the EU MDR 2017/745 and follow the MDCG 2020-6 guidelines, as expected by the Notified Body.
For more information, visit: https://clinicalstudytemplates.com/clinical-evaluations-mdr/