We have a medical device that we developed and we plan on getting approval in Europe (CE mark) and states (FDA) but we cannot measure one of the constituents of the formulation. I.e we cannot quantify/qualify that one of the materials we add during production is present and we can’t quantify it.
Is it required that we must be able to measure Quantitatively and/or qualitatively detect it(i.e. is it present?)?
Is it sufficient to risk assess it? And what risk assessment would be suitable to ensure safety to user
Ps the percentage in finished device is < than 1%