Clinical Evaluation of Medical Device – I3CGLOBAL

 

The clinical evaluation of medical devices is undoubtedly one of the cornerstones of the new regulation. It is a very complex institution, the application of which requires an in-depth analysis of the regulation itself and which can help to dispel some doubts.

 

What is clinical evaluation?

The clinical evaluation is a systematic and planned process aimed at continuously producing, collecting, analyzing, and evaluating clinical data relating to a device to verify its general safety and performance, including clinical benefits, when it is used as intended by the manufacturer. 

 

It is therefore a business process that must be "systematic" and "programmed" and which aims to produce clinical data. The collection and analysis of such data serve to verify the safety and performance of the medical device.

 

What is clinical data?

Clinical data is information relating to the safety and performance of the device. Such data can come from 4 sources”

 

●        Clinical investigations relating to the device in question.

●        Clinical investigations or other studies published in the scientific literature relating to a device whose equivalence to the device in question can be demonstrated.

●        Reports published in the peer-reviewed scientific literature on other clinical experiences relating to the device in question or to a device whose equivalence to the device in question can be demonstrated.

●        From clinically relevant information from post-marketing surveillance, especially post-marketing clinical follow-up.

 

Why Should We Do Clinical Evaluation for Medical Devices?

 

Under Article 61, the clinical evaluation serves a

 

●        confirm compliance with the relevant general safety requirements

●        confirm the performance of the medical device

●        evaluate unwanted side effects

●        Assess the acceptability of the benefit-risk ratio.

 

The clinical data that are used for the confirmations and evaluations of the above must provide sufficient clinical evidence, also using the relevant data.

 

What is the relevant clinical data?

The relevant data are those that emerge from the post-marketing surveillance of that particular device (Annex III).

 

Who should carry out the clinical evaluation?

All manufacturers of medical devices must carry out the clinical evaluation, precisely because it serves to prove compliance with safety and performance requirements, as well as to evaluate side effects and the cost-benefit ratio. What changes between the Class I and Class III medical devices is the level of clinical evidence.

 

Article 61 states that: “The manufacturer specifies and justifies the level of clinical evidence necessary to demonstrate compliance with the relevant general safety and performance requirements. 

 

This level of clinical evidence must be appropriate in consideration of the characteristics of the device and its intended use ". The level of clinical evidence may be higher or lower depending on the type of DM.

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