EXPERTISE

Medical device law

We provide legal advice to small and medium-sized entrepreneurs of medical devices thereby covering all issues related to medicinal product law with particular expertise on medical devices similar to pharmaceutical drugs (so called substance-based medical devices).

We support entrepreneurs of medicinal products in the conduct of clinical trials connected to the development of medical devices and we actively accompany conformity assessment procedure. Our legal advice includes the reimbursability of medical devices as well as the lawful design of packaging and legal certainty of merchandising concepts.

We represent our clients vis-a-vis national and European authorities and notified bodies. If necessary we assert the rights of our clients in court.

Areas of focus

  • Borderline of in vitro diagnostics/pharmaceutical drugs/cosmetics/food product
  • Conformity and certification procedures
  • Clinical trials with medicinal products
  • Reimbursability
  • Product design and labelling
  • Advertising
  • Parallel-imports
  • Product liability
  • Client-specific in-house training regarding all issues related to medicinal products law