Medical Devices Law

Given the number and diversity of the medical devices on the market, dispensing legal advice to manufacturers of medical devices requires broad experience both in relation to the interplay of national and European standards, and with regard to the requirements of technical documentation and the influence of international standards (technical norms).

Our law firm guides small and medium-sized enterprises as well as large medical device manufacturers and research institutions in the following areas: development and testing of medical devices, correct classification as a medical device (in comparison to in-vitro diagnostic products, software or accessories, for example), implementation of the required conformity assessment procedure and CE marking, product information design (labelling and operating instructions) and the marketability of product combinations (e. g. advanced therapies).

We assist our clients in their cooperation with national and European authorities and committees and with Notified Bodies, as well as asserting their rights in court. Market surveillance and the implementation of corrective measures (CAPA) are as much a part of our expertise as contesting product liability claims.