Remember to adapt the Literature Search Protocol & Report to the specific requirements of your medical device, the Australian regulatory environment, and any internal organizational processes. It's also crucial to involve experts in the field to ensure the quality and validity of your systematic literature search and evaluation. Always consult relevant regulations and guidelines in Australia and seek expert advice when necessary. https://mavenprofserv.com/literature-search-protocol-report/

1. LITERATURE SEARCH
PROTOCOL & REPORT

2. CONTENT
Systematic Literature Search
Protocol and Report
Statements of The Art
Evaluated Device
Systematic Literature Search
Protocol
Systematic Literature Search
Report

3. 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. 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.

4. 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 PRISM A or M OOSE m ethods for
literature search.

5. 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

6. Evaluated Device
Intended Purpose
Safety and performance parameter claims
Data on equivalent device
Device Nam e / M anufacturer’s Nam e
Indication under evaluation
Patient population affected

7. 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)

8. 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
Methods:

9. Strategies for avoiding retrieved data already held by the
manufacture
Data collection plan
Appraisal plan
Deviations

10. 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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