The clinical evaluation is the document that collects and analyzes the set of clinical data on the medical device or equivalent devices and all information on state of the art in the specific sector in which the medical device is used.

It aims to evaluate the benefit/risk profile from the clinical point of view of using the medical device and is therefore related to the risk analysis, just as it aims to demonstrate the fulfillment of the relevant essential requirements.

The clinical evaluation starts with developing a previously planned process and is carried out in the drafting of a report document.

It must be updated periodically or as soon as it becomes aware of information that may affect the conclusions of the assessment itself; collects the info coming from supervisory and surveillance activities; critically analyzes the relevant medical-scientific literature and must evaluate, when present, the clinical investigations carried out with the medical device.

The clinical evaluation process described in the so-called Old directive is less demanding that the same one required by the MDR. But in the meantime, in June 2016, there was a guideline called MEDDEV 2.7/1 revision 4 published.

And the requirements in this guideline are quite similar to those that are described in MDR. Saying it simply, any clinical evaluation that should survive under the MDR should now follow all the MEDDEV dimension principles.

But what exactly are the differences?

There are a couple of significant differences, But let’s try to point out some important ones. For example, there is a fixed frequency of clinical evaluation report updates.

For new medical devices or higher risk medical devices, you have to update your report annually. For fewer risk devices and well-known ones, two to five years are frequent.

You have to justify and document the plant frequency in your clinical evaluation plan. And please don’t forget that you have to update your clinical evaluation.

Also, whenever any new information, which affects the assessment or its conclusion, appears, is there any difference between the processes when you have a low-risk device, which you want to keep on the market compared to a low-risk device get on the market?

The Best Clinical Evaluation Report Writers have to have a higher education degree and at least five years of relevant professional experience.

And if they don’t have a higher education degree, they have to have at least ten years of relevant professional experience. Moreover, expertise must cover three areas—first, the appropriate clinical specialty, second, the medical writing and research methodology.

And third, the information management because identifying all available resources of relevant clinical data is one of the vital parts of one of the essential clinical evaluation roles.

And of course, all of them have to be familiar with the medical device topic generally and with the technology of the device concern itself.

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