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A Summary of the European Commission’s EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
For a current copy of the guidance document you can visit the EC’s website.
As part of the conformity assessment procedures required by 90/385/EEC (AIMD) [1] and 93/42/EEC (MDD) it is the manufacturer’s responsibility to review and analyze clinical data. Clinical data is often required to demonstrate safety and effectiveness (performance) of a medical device.
The European Commission’s EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES provides a roadmap on assessing clinical data.
What is considered “Clinical Data”?
Clinical data can be either the results of a clinical investigation or it can be via literature, or a combination of the two.
In the circumstances where a combination of clinical investigation and literature is used, an overall assessment should be made, paying special attention and relating the information back to any market experience (if available). The standard indicates that the manufacturer should relate the data as it pertains to the device – and specifically to the hazards identified.
Technical File: Statement Affixed to the CE marking
The manufacturer’s technical file should have a statement on the clinical data. It is important to note in the technical file whether the data used was collected from:
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Clinical Investigation
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Literature
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Or both
The technical file should include the complete set of clinical data.