Systematic Literature Review & Clinical Evaluation
A systematic literature review is a vital component of the Clinical Evaluation of medical devices. It is also challenging to perform and is an aspect of Clinical Evaluation that can be a source of confusion, difficulty and non-conformity.
In this article – the first in a series on Appendix 5 of Meddev 2.7/1 rev 4 – we begin the process of demystifying the process of systematic review of literature for Clinical Evaluation.
What is Meddev 2.7/1 rev 4?
Meddev 2.7/1 rev 4 is one of a series of guidance documents published by the European Commission intended to assist medical device manufacturers and Notified Bodies in meeting medical device regulatory obligations. Meddev stands for MEDical DEVices documents. Meddev 2.7/1 rev 4 is a detailed document which sets out comprehensive guidelines for medical device manufacturers and notified bodies for the conduct of Clinical Evaluation. Meddev 2.7/1 rev 4 is a technical document which can be challenging to digest.
Appendix 5 of the Meddev guideline sets out requirements for the identification and review of literature in the context of Clinical Evaluation. It is therefore central to performing a compliant literature review.
What is the role of a literature review in medical device Clinical Evaluation?
The review of published literature is a critical component of medical device Clinical Evaluation. A literature review is performed to inform two major elements of a Clinical Evaluation:
- A review of the current knowledge/ the state of the art – this enables the identification of safety and performance benchmarks against which performance of the subject (and, if relevant, equivalent) device may be evaluated
- A review of literature relating to the subject (and equivalent) device.
It is a requirement that literature reviews are performed according to a documented protocol and that they include both favourable and unfavourable data. They must be representative and not be biased or selective; therefore, methods must be set out clearly for inclusion, exclusion, appraisal and analysis of sources.
What guidance is offered by Meddev 2.7/1 rev 4 Appendix 5?
Appendix 5 of Meddev 2.7/1 rev 4 provides a range of guidance for Clinical Evaluation literature reviews, including:
- Offering general instructions on literature searching
- Outlining methods for constructing protocols for undertaking a literature review
- Defining the key elements of literature reviews that are required in order to deliver a compliant Clinical Evaluation Report.
Understanding the literature search and review process explained in Appendix 5 can be made easier by dividing it into four stages:
Stage 1 Background
- Search criteria
- Inclusion & exclusion criteria
Stage 2 Literature Screen
- Analysing abstracts
- Full article
Stage 3 Analysis & Appraisal
- Selection & Exclusion
- Critique & Appraise
Stage 4 Literature Report
- Benefits / Risk
In this article series, we will take a deep dive into each of these stages.
Stage 1: Background to the literature search
Background to the literature search stage sets the scene for the substantive literature search, review, appraisal and report to follow. Performed properly, a rationale for performing the literature review should be clearly documented.
The background to the literature search should include information such as:
- Name of the device/model.
- Importance of literature review in the risk management process. The review should provide data on current therapies, diagnostic measures, and measures for the management of medical conditions for the targeted patient population. This will help in order to assess the acceptable benefits/risks.
- Outcomes of previous literature reviews and literature searches conducted by manufacturer.
- Identification of any equivalent or benchmark devices to be included in the evaluation, including the name and model of these devices.
Carefully formulated research question(s) should be set out to guide the selection of search terms. Selected search terms will then be subjected to an objective, non-biased, systematic search and review. The inputs required for this section are the device description and the expected device performance; these can be applied for the formation of relevant research questions. Methods or protocols adopted for the conduct of literature review should set out the search methodology, sources of data, selection & exclusion criteria and appraisal/critique methodology.
The next article in this series focuses on Stage 2 and 3; the methods and plans for literature search & screen, selection, appraisal and analysis. Subscribe to our Newsletter to get notified when we publish our next article.
About Mantra Systems
Mantra Systems specialises in Systematic Literature Reviews and Data Analysis as part of our Clinical Evaluation service. If you would like to speak to us about how we could help you in this area, please contact a member of our team for a no-obligation discussion.
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