Literature Appraisal Template

Literature appraisal, as a core component of Clinical Evaluation, is a critical process that ensures published scientific and clinical data are systematically identified, assessed, and validated for their relevance to the device under evaluation. This Literature Appraisal Template is specifically developed to support manufacturers in meeting clinical evaluation requirements by providing a structured, regulator-aligned framework for the consistent collection, review, and critical analysis of literature in accordance with Regulation (EU) 2017/745 Annex XIV, MEDDEV 2.7/1 Rev. 4, and MDCG 2020-13. It enables objective assessment of study quality, clear determination of clinical relevance, and robust linkage between published evidence, clinical performance, safety outcomes, and benefit-risk conclusions.

By standardising the appraisal process and ensuring appropriate weightage of evidence in terms of qualitative and quantitative scoring, the template strengthens the scientific validity of the Clinical evidence for the product in the Clinical Evaluation File.

Designed by experienced regulatory professionals keeping Notified Body expectations in mind, this template provides a practical, compliant, and efficient solution for manufacturers seeking to streamline their clinical evaluation activities without compromising on regulatory rigour.

Price: $300