Literature Review Templates

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/

State-of-the-Art (SOTA)

The State-of-the-Art (SOTA) section is considered as one of the most confusing, ambiguous, and challenging parts of a Clinical Evaluation Report (CER).

Contrary to popular believe, SOTA is not about the latest and greatest technological novelties on the regulated market. Instead, it defines the clinical landscape in which the medical device under evaluation is used in order to determine how the safety and performance of the subject device fit in and compare to competitor, similar, and benchmark devices (i.e., comparator devices) as well as alternative treatment options that are available to patients. In other words, SOTA sets the stage that allows for an objective risk-benefit profile assessment of the subject device.

The CER Template contains a pre-populated SOTA section with clear guidelines on identifying, collecting, and organizing relevant clinical and scientific information needed to establish the SOTA of your subject device, as expected by Notified Body (NB) review of CERs in compliance with the EU MDR 2017/745.

For more information, visit: https://clinicalstudytemplates.com/clinical-evaluations-mdr/