Systematic Literature Search Protocol & Report

Click here to Literature Search Protocol & Report Template

MEDDEV 2.7/1 Rev. 4 states that the manufacturer’s systematic literature search shall cover at least two important things:

• State of art search: to demonstrate the state of art of the device and evaluate your device in comparison
• Statements on your own device or equivalent device to demonstrate safety, performance and clinical benefit.

The systematic literature search will retrieve a large number of literatures for a given search term and at this time you may wonder whether it is necessary to read the full text of each publication. You don’t have to read the full texts of all the literatures retrieved during the search. You can exclude non-relevant literatures on the basis of the abstract if they are not related to the clinical evaluation of your device.

Systematic Literature Search Protocol (LSP)

The systematic literature search protocol should be prepared as per the requirement of Appendix A5 of MEDDEV 2.7.1 and verify the same as per the requirements mentioned in “Section D of MDCG 2020-13– Clinical Evaluation Assessment Report Template” to save time.

The systematic literature search protocol contains information about the planning of literature search and documenting it. The systematic literature search protocol should specify the requirements mentioned below:

• Background of literature search and the literature review
• Objective: which should be consistent with the scope of the clinical evaluation and carefully constructed using a process (e.g. PICO)
• Methods:
  • Literature search methodology
  • Source of data (As per Appendix A4 of MEDDEV 2.7.1 REV. 4)
  • The database search strategy
  • Which electronic database is used to search along with justification
  • Search terms used for the identification of literature
  • Limit of start and end dates for each search term
  • Inclusion and exclusion criteria
  • Strategies to avoid duplicate data
  • Strategies for avoiding retrieved data already held by the manufacture
  • Data collection plan
  • Appraisal plan
  • Deviations

Literature Search report (LSR)

A literature search report shall be prepared after the completion of the literature search. LSR should contain information about deviation and search result from the literature search protocol. This LSR along with LSP becomes part of the clinical evaluation file.