At national level, the courts are becoming increasingly concerned with drawing the line between medicinal products and medical devices, focusing primarily on the scientific background of the products.

We assess the categorisation and classification of product ideas, provide advice on selecting a suitable conformity assessment procedure and oversee the creation of QM systems. If there is a need to involve a notified body, we can help you to choose the right one. We can also draw up technical documentation including clinical evaluations and risk analyses for our clients.

We update clinical evaluations and risk management files including risk analyses in line with current standards for products which have already been declared compliant. In the event of any doubts concerning the categorisation of medical devices, which are becoming increasingly important, we analyse the available data regarding the mechanism of action and produce classification reports based on the findings.