Bioartifizieller Organersatz

The study identifies where the current legal framework for bioartificial organ transplants requires reform and develops a series of reform proposals. To this end, it provides the necessary scientific basis and analyzes the legal status of bioartificial organ transplants. In addition, the requirements for the manufacture of organ transplants are examined, considering the EU Commission's proposal for a SoHO Regulation. The thesis then looks at the requirements for the marketing authorization and clinical trial of bioartificial organ transplants, with consideration of placebo surgical controls. Finally, the requirements for the transplantation of organ transplants are examined in more detail.