Clinical Affairs deals with all aspects of the performance evaluation of your IVD medical device. The aim of all activities is to demonstrate that the IVD medical device actually delivers the clinical benefit in practical application that was traded off against the risk in the risk management process. The clinical benefit of the device must be proven by data and observed and confirmed throughout the entire product life cycle.

Already in the initial phase of a device’s development, a systematic literature research in scientific databases should be conducted to prove the scientific validity: On the one hand this serves to ensure that known risks of similar products on the market may be excluded for your device; on the other hand it clearly reveals the present state of the art for your technology. These search results are then seamlessly integrated into your product development requirements. You are already familiar with possible comparable products as well as available clinical data. During the course of the further development process, a performance evaluation is prepared and filed as a central document for technical documentation; it is an obligatory prerequisite for CE marking.

No, because as the manufacturer you must ensure a safe and efficient product throughout the entire product life cycle. There are different possibilities to define suitable post-market performance follow-up (PMPF) activities in the scope of post-market surveillance (PMS) such as participating in ring trials, evaluating defined questions with a statistically significant number of patients, long-term observation of patients, or investigations about known risks in literature. Based on this data you identify possible problems of your product, eliminate them at an early stage and thus increasingly adapt your successor products to your users’ needs.