[TECH LETTER] Claims and their substantiation

This Downloadable Techletter discusses Article 7 of the MDR & IVDR and its implications in terms of the safety and performance data required to substantiate a given claim.


The claims made by a manufacturer regarding the intended use, safety, and performance of their medical device or IVD medical device, both in their form and content, indubitably play an important role toward the commercial success of their product.


It is therefore in the manufacturer’s interest to formulate the most appealing claims possible on the device. This can in certain cases lead to the communication of exaggerated or ambiguous claims on the device, particularly in, but not limited to, promotional material.


It is however imperative for manufacturers to have a clear understanding of what they are allowed or have the obligation to communicate to the user or patient regarding the intended purpose, safety, and performance of their medical devices.


MDR/IVDR Article 7 states in essence that device manufacturers may not communicate any claim on the device which is not adequately supported by objective data. In this context, manufacturers should early in their device development stages define plans and methods in order to capture the safety and performance data necessary to substantiate any claim they intend to make on their devices.



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