Literature Review Protocol (LRP) and Report (LRR) Templates + Assessment Worksheets

Description

This is a complete package that includes the 2 essential document templates for an EU MDR 2017/745-compliant Notified Body (NB) submission, and 3 worksheets:

• Literature Review Protocol (LRP)
• Literature Review Report (LRR)
• Device-specific, SOTA, and Comparator Literature Assessment Worksheets

The Literature Review Protocol (LRP) Template is specifically designed to be used in conjunction with the Literature Review Report (LRR) Template, and intended for straightforward transfer of information from the LRP into the LRR.

The Literature Review Report (LRR) Template is specifically designed to be used in conjunction with the Literature Review Protocol (LRP) Template.

The Literature Assessment Worksheets are 3 separate MS Excel Files (one for each literature category: Device-specific, SOTA, and Comparator) with multiple tabs that sequentially guide the user through the process of literature collection, selection, and data extraction for easy incorporation into the LRR.

The sections of these LRP and LRR Template include all the fundamental components of an EU MDR 2017/745-compliant literature review. The structure and sections as well as their order and content follow the MEDDEV 2.7/1 Rev. 4 guidelines and Medical Device Coordination Group (MDCG) 2020‑6 and MDCG 2020‑13 recommendations conforming to the expectations by the Notified Body (NB). Moreover the layout is in alignment with the Clinical Evaluation Report (CER) Template for straightforward transfer of information from the LRR into the CER.