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Factors to keep in mind preparing for Clinical Evaluation.


Clinical data allows manufacturers to make decisions and conclusions on the safety and performance of their devices.   It enables manufacturers to quantify the risk/benefit ratio of the medical device. The EU MDR has greatly impacted the way medical devices are regulated and as part of this, manufacturers need to create and maintain clinical evaluations.


The Clinical Evaluation Report (CER) is an essential component of the conformity assessment of a medical device. Their purpose is to provide a comprehensive summary of the device’s design and composition, its intended applications and any applicable literature reviews. CERs can be extensive, depending on the scope of the evaluation needed.  Overtime manufacturers will be able to identify the most appropriate approach and templates that reflect their needs. 


What needs to be considered when preparing for and performing clinical evaluations efficiently? In summary, manufacturers should:

To lessen the burden on manufacturers and their representatives when completing clinical evaluations for their medical devices, keep the following factors in mind:


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