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A Summary of the European Commission’s EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

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Identification of Literature

In most circumstances you should base your literature on recognized scientific publications, giving rationale on why this data was picked from the specific literature.  In order to avoid being bias the identification of literature should also include reasons why other publications/data was excluded.  To ensure that your organization has adequately gone through all relevant information, you should indicate the extent to which sources of information were searched.

Your protocol should state how the literature will be searched and will include the criteria on which the selection is based.  Including justification on how other sources of data become excluded in the effort.

Relevance of Data

The manufacturer must demonstrate how the literature relates to the device.  This demonstrated equivalency should touch on the clinical, technological and biological (biocompatibility, material content, etc) aspects of the review.

Assessing Data

While excluding data originating from unsubstantiated opinions, isolated cases or nonscientific information data is best obtained when deriving from scientific/clinical trials.  Clinical Trials data is best if the conditions of the trial were controlled.

Critical Evaluation of the Literature (Literature Route)

As indicated above the critical evaluation should be done by an individual best suited for the task.

A table of content for the Critical Evaluation might look something like this:

• Medical Device Description

• Medical Device’s Intended Use (Functions)

• Analysis of Available Data (Favorable and Unfavorable)

• Equivalency (between Literature and Device; including equivalency between the device and other devices on the market)

• Hazards Identified

• Description of Literature Review and Assessment

• Discussion on Efficacy of the studies in question

• Benefits of the Device (how it improves upon previous designs, methods, etc)

• Conclusions (demonstrating how objectives were met/not met)

• Signatures (Author, Review and Approved by, etc)

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