Literature Search Protocol & Report

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LITERATURE SEARCH PROTOCOL REPORT
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CONTENT
Systematic Literature Search Protocol and Report
Statements of The Art Evaluated
Device Systematic Literature Search
Protocol Systematic Literature Search Report
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Systematic Literature Search Protocol and Report
Systematic 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. Its 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.
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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
systematic 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. methodology by using
One can also adopt sound non-biased
PICO or PRISMA or MOOSE methods for
literature search.
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Statements of The Art
Clinical background of device Applicable standard
and regulation Data on similar device Alternate
medical treatments Indication under evaluation
Patient population affected
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Evaluated Device
Intended Purpose Safety and performance parameter
claims Data on equivalent device Device Name /
Manufacturers Name Indication under
evaluation Patient population affected
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Systematic Literature Search Protocol
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)
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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

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Strategies for avoiding retrieved data already
held by the manufacture Data collection plan
Appraisal plan Deviations
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Systematic Literature Search Report
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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