Literature Search Protocol

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Literature Search Protocol

Medical Device Literature Search Protocol and Review Strategy

To plan and keep a record of the identification and review of relevant clinical data obtained from a literature search in response to review questions on safety, performance, undesirable side effects, and risk-benefit analysis.

The scope is limited to medical devices planned for a clinical evaluation using clinical data obtained from works of literature. Medical Device Literature Search and Review plan should be developed and executed by identified persons with expertise in information retrieval, having due regard to the scope of the clinical evaluation.

Medical Device Literature Search results and conclusion should include the data derived from each literature and its relevancy to answer the review question. If the data is not enough to conclude, it should justify, and more data requirements should be specified.

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Literature Search Protocol and Review Services

Literature Search and Review Plan

People with information retrieval expertise should be prepared and implemented who are aware of the clinical evaluation’s scope. I3CGLOBAL team are medical device literature reviews expert

Scientific Literature Search

Start the search with MEDLINE or PubMed.
Additional databases such as European PMC shall be searched to ensure the adequate coverage of devices and therapies in use in Europe, to identify relevant clinical trials and publications of user experience.
Proceed with the search by using device name and manufacturer (e.g. EMBASE (biomedical literature database) /Excerpta Medica, the Cochrane CENTRAL trials register, etc.).
Due to frequent changes in information coverage and search features available in scientific databases, the justification for selecting adequate databases must be defined and re-evaluated on a regular basis.

Medical Device Literature Search Protocol / SOP is essential to conduct a systematic scientific literature search and review and approval from Notified Bodies.

Internet Searches

General internet searches like Google Scholar, Competitor manufacturer websites

Non-published Data Identification

The label and IFU of the equivalent device (the manufacturer should claim the equivalence) and/or benchmark devices and other devices.

Citations referenced in Scientific Literature

The citations of the scientific literature given in the sites like Scopus and Web of Science, if required, should be identified.

The Literature search output should list out the selected literatures with the citations and its relevancy towards the aspects of intended use, target population, indication, etc and recorded in the report

Preparation of Literature Search and Review Report

The number of medical device literature reviews questions should be used to guide the literature search and review report(s). Summary on the background for the type of search done, eligibility criteria for the selected literatures should be given in the introduction sections. The Materials and Methods section should include the details of devices used i.e , if equivalent, similar or benchmark devices, any particular method for using should be specified.

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The medical device Literature search templates, covering Literature search and Review procedure and SOP, Appraisal of Clinical Data, Demonstration of Equivalence, Analysis of Clinical Data, Literature search and Review Plan, Literature search and Review Report, etc.

We have developed Medical Device Literature Search Protocol and Record Templates in line with MDR requirements. These templates are ready to buy online.

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FAQ's

Explain Clinical Evidence

Clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer.

Explain Clinical Performance

The ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer.

Explain Clinical Data

Information concerning safety or performance that is generated from the use of a device and is sourced from the following:
• clinical investigation(s) of the device concerned
• clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated
• reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated
• clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up

Importance of Medical Device Literature Search Reviews

Because a robust and systematic literature research approach fortifies every stage of the medical device life cycle process from idea and design, literature reviews are critical to the success of CER documentation. As a result, screening the literature to ensure compliance with the CE Notified Body throughout the approval process and for post-market surveillance is critical to the success of any MDR CE Certification medical device.

For many small and medium-sized device makers, the data received via literature searches will constitute the majority, if not the entirety, of the data collected. As such, this search discovers clinical data sources for establishing current knowledge or “the-state-of-the-art” that describes the clinical background in the appropriate medical sector, clinical data relevant to the device under assessment, or an analogous device. That is why it is crucial to build a comprehensive literature search method that can be repeated by anybody throughout subsequent upgrades.