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Literature Search Protocol & Report

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Literature Search Protocol and Literature Search Report

Literature Search is a key part of clinical evaluation and an alternative pathway to clinical trials in order to prove the clinical safety and performance of your device. It’s a tedious process and involves numerous hours of work. In the literature search the manufacturer of device collects scientific articles to document state of art, safety and performance data and clinical benefits of the device.

Scientific literature search

As defined in MEDDEV 2.7.1. rev. 4, literature search is used to identify data not held by manufacturer that are required for clinical evaluation.

A systemic literature search forms a great source of clinical evidence to validate the safety and performance of the already existing devices in their commercialization approval process.

A literature search, if done systemically, can reduce the need to generate relevant data through clinical investigation of the medical device under consideration. Therefore, a good database search knowledge is mandatory. Examples of database include MEDLINE or PubMed, EMBASE, Excerpta Medica, the Cochrane Central Trials registries, WHO International Clinical Trial Registry Platform (ICTRP), and Clinical Trials.gov. One can also adopt sound non-biased methodology by using PICO or PRISMA or MOOSE methods for literature search.

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Literature Search Protocol and Literature Search Report

Literature Search is a key part of clinical evaluation and an alternative pathway to clinical trials in order to prove the clinical safety and performance of your device. It’s a tedious process and involves numerous hours of work. In the literature search the manufacturer of device collects scientific articles to document state of art, safety and performance data and clinical benefits of the device.

Scientific literature search

As defined in MEDDEV 2.7.1. rev. 4, literature search is used to identify data not held by manufacturer that are required for clinical evaluation.

A systemic literature search forms a great source of clinical evidence to validate the safety and performance of the already existing devices in their commercialization approval process.

A literature search, if done systemically, can reduce the need to generate relevant data through clinical investigation of the medical device under consideration. Therefore, a good database search knowledge is mandatory. Examples of database include MEDLINE or PubMed, EMBASE, Excerpta Medica, the Cochrane Central Trials registries, WHO International Clinical Trial Registry Platform (ICTRP), and Clinical Trials.gov. One can also adopt sound non-biased methodology by using PICO or PRISMA or MOOSE methods for literature search.

MEDDEV 2.7/1 Rev. 4 states that the manufacturer’s 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.

Statements of The Art

  • Clinical background of device
  • Applicable standard and regulation
  • Data on similiar device
  • Alternate medical treatments
  • Indication under evalution
  • Patient population affected

Evaluated Device

  • Intended Purpose
  • Safety and perfomance parameter calims
  • Data on equivalent device
  • Device Name / Manufacturer’s Name
  • Indication under evalution
  • Patient population affected

The 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.

Literature Search Protocol (LSP)

The 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 literature search protocol contains information about the planning of literature search and documenting it. The 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.

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