A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. A Clinical Evaluation is required for all medical devices to be marketed in Europe. Alternative treatment options including no treatment should be considered as part of the Clinical Evaluation.
As a medical device manufacturer, one would expect that by using your device, a safer and better clinical outcome would occur as opposed to not using your device. In other words, the benefits of using your device should outweigh the risks. However, if the Clinical Evaluation fails to show a high degree of clinical safety and performance from the use of the device, the device may be deemed too risky and denied market access.
Certainly, a Clinical Evaluation performed on a medical laser over 50 years ago, would have likely concluded the laser too risky to use. Today, lasers are commonly used safely for many surgical procedures. Unique or novel treatments will likely encounter un-favorable Clinical Evaluations and barriers to the market.
Conformity Tech can help you navigate through these regulatory hurdles.