What is the clinical evaluation of a medical device?

A clinical evaluation assesses the clinical data of a medical device or IVD medical device to establish that a favourable benefit-risk determination exists for the device in question when used as intended by the manufacturer.

As such, the clinical evaluation comprises the analysis of:

???? Clinical investigation reports (for IVDs: clinical performance evaluation reports) undertaken under the Declaration of Helsinki principles and ISO 14155;
????️ Published scientific literature/reviews of the state of the art (SOTA) and current clinical guidelines;
???? Clinical experience with the device and similar devices derived from post-market surveillance (PMS).

In this evaluation, we compare the performance and safety of the device according to the SOTA, which embodies what is currently and generally accepted as good practice in technology and medicine, and does not necessarily imply the most technologically advanced solution (i.e., the “generally acknowledged state of the art”).

Also, as a way to assess the benefit-risk of using the device, during the clinical evaluation it is also fundamental to verify that the manufacturer has and maintains a quality (QMS: ISO 13485) and risk management system (RMS: ISO 14971) to ensure the ongoing quality, safety and performance of the device. The risk management of a medical device or IVD medical device is a continuous iterative process throughout the entire lifecycle of the product, requiring regular systematic updating (TPLC) that is assessed during the clinical evaluation.

The risk of using the device needs to be reduced to an acceptable level as determined by the manufacturer and regulatory authority without adversely affecting the benefit-risk ratio (i.e., reducing risk as low as reasonably practicable, reducing risk as low as reasonably achievable, or reducing risk as far as possible). Furthermore, the manufacturer should always inform the user of any relevant residual risks, which are also assessed during the clinical evaluation.

Additionally, the clinical evaluation also examines if there are any other consensus standards that may be used to demonstrate conformance with the essential principles of safety and performance of a medical device or IVD medical device. These consensus standards give a greater level of detail and specificity in terms of safety and performance of the device; although, the use of these consensus standards is voluntary, and manufacturers may establish alternative ways to demonstrate that they meet the essential principles.

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Reference: https://lnkd.in/dPW9_aDi