Table of content

📌 1.0 Literature Review Process Overview

Report Compliance Statement

The Literature Review Report is designed with a specific protocol in order to assist a manufacturer seeking IVDR certification compliance in Europe. As such, the process will conform to the following Regulations and Guidance Documents:

• EU IVDR - 2017/746
• MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medial devices (IVDs)
• MEDDEV 2.7.1 Rev4

The full process of our literature review can be broken into the following steps:

• Search terms are determined and the protocol is defined

  • The process begins with determining the search terms (more details provided in section 2.0). The search protocol is then drafted which lays down the path forward to carry out the literature review process including information such as the search timeline, search database, inclusion/exclusion criteria etc.

• Searches are run and the results are compiled for review

  • In this phase, all search terms are run across all chosen databases and the results are prepared for review.

  The main steps are:

  • Run search terms on all databases
  • Download results
  • Remove (and count) duplicates for each search.
  • Prep abstracts, citations, titles, and full texts (if available freely) for review.
  • Note* The above steps are completed with the assistance of CiteMed’s Literature Review System. Such efforts can be duplicated manually if the client ever desires

• The abstract review takes place

  • In this phase (1st Pass Screening), all of the abstracts (minus the duplicates) will be reviewed by the CiteMed Reviewer.
  • Sufficient information on the relevance of the article based on the Abstracts and Title review comprises the bulk of the review. In this step, the reviewer will decide to exclude articles that are clearly meeting the exclusion criteria. If the reviewer could not take a decision based on the information available in the abstract and title, the article will be moved to the next pass (2nd pass screening) for full-text review.
  • However, some full texts are not available during this review for particularly challenging decisions, these articles will be moved to 2nd pass screening.
  • For each article reviewed in this step, there are only two possible outcomes; include or exclude
  • The included article will move for further review (Long Form Extraction Field Table)
  • The article is Excluded with a descriptive reason (reasons defined in Search Protocol).

• Full texts are retrieved and organised for review

  • In this step, a list is compiled of all Included articles (from the previous step). The CiteMed team will then source freely or purchase the Full Text of each article.
  • Below is an illustration of the process of article review:

  Review Flow Chart

  

• Data extraction from retained articles occur

  • For Basic Project: In this step, each Included article is reviewed at the Full-Text level. Detailed ‘Extraction’ criteria are filled in for each article. Data Extraction is only applied to Retained Articles that are Related to the Device Under Evaluation (DUE).
  • For Standard Project: In this step, each Included article is reviewed at the Full-Text level. Detailed ‘Extraction’ criteria are filled in for each article. Data Extraction is applied to Retained Articles that are Related to the Device Under Evaluation (DUE) and Similar devices. The safety and performance criteria will be fixed based on similar device data extracted in the Long Form Extraction Field Table.
  • For Comprehensive Project: In this step, each Included article is reviewed at the Full-Text level. Detailed ‘Extraction’ criteria are filled in for each article. Data Extraction is applied to Retained Articles that are Related to the Device Under Evaluation (DUE) and Similar devices. The safety and performance criteria will be fixed and a complete SOTA section will be developed covering (i) the Disease Background, (ii) the Alternative Therapy/Option and (iii) the Similar Devices sections.