Claims and their proof in the clinical evaluation

In connection with the MDR, “Claims” refer to claims or statements made by manufacturers about the intended use, performance or benefit of a medical device. These claims may include a wide range of aspects related to the product, including the intended purpose, application indications, efficacy, safety and any other features that may be relevant to the performance or benefit of the product. Claims relevant for clinical evaluation can be found in the technical documentation, but also often in marketing documents, etc.

The MDR, but also the FDA, for example, require that every claim can be objectively proven, e.g. with clinical data. The “proof” of claims is often a challenge that should not be underestimated.

In this article we would like to give you the answers of our expert Prof. Michael Imhoff on the many exciting questions presented by our customers: