Manufacturers who wish to place products that contain both, a drug component and a device component on the European market, face a special challenge.

These so-called combination products are either governed by the rules and regulations concerning medicinal products or by those concerning medical devices. This depends on which component causes the principal action. You are welcome to call on us to support you in demarcation issues. In any case the requirements of the respectively corresponding rules and regulations have to be met. This circumstance increases the complexity of the necessary documentation as well as of the required assessment procedures.

Our services cover the entire development and life cycle of such products, ranging from consultancy services alone over the compilation, editing and assessment of documentations, expert opinions, biological and clinical evaluations to the necessary experimental and analytical tasks required to prove conformity. For products that might be classified as medicinal products (borderline products), we compile position papers for classification.

We also offer our support concerning Scientific Advice meetings with authorities and the performance of the consultation or certification procedure.

drug-device combination products
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