Portfolio expansion – Clinical Study Templates now also offers Literature Review Protocol (LRP) and Literature Review Report (LRR) templates including an Excel Worksheet to organize the literature as part of the clinical evaluation process required to place and/or retain Class I-III medical devices on the EU market. These templates contain all the essential aspects for European Union (EU) Medical Device Regulation (MDR) 2017/745-compliant submissions to the Notified Body (NB), as recommended by the MEDDEV 2.7/1 Rev. 4 and the Oxford Centre for Evidence-Based Medicine (OCEBM) guidelines on the search, identification, collection, selection, and assessment of scientific clinical literature of the subject device as well as the State-of-the-Art (SOTA), including comparator devices (i.e., similar, benchmark, and competitor devices).
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/