Claims, or in other words the commitment of a company over the performance and safety of the product, are often a major concern to both regulators and marketers.
Regulators demand that the claims are based on scientific data, clinical data and must reflect the current state of knowledge. In fact, the claims must clearly and unambiguously state and be based on the device’s intended purpose, it’s safety or performance, as per MDR 2017/745, article 7.
Marketers, on the other hand, are asked to best describe and advertise the product with supportive figures, videos, and other information. Thus, the virtuosity of the marketer is limited by the regulations.