Dirk Lanzerath Boeken

Medical devices include objects, substances, and software that are used for therapeutic or diagnostic purposes for humans. However, the main intended effect, in contrast to medicinal products, is not primarily pharmacological, metabolic, or immunological, but usually physical or physicochemical. The innovation cycles for many modern implantable medical devices are estimated to be about 18 months, for software even shorter. It is obvious that the evaluation of the performance, the effectiveness, the benefits, and risks of a medical devices is very different compared to medicinal products. The recent EU-Regulation on medical devices asks for very requirements regarding the systematic evaluation of medical devices in humans and the procedures for granting the CE mark. The recent volume of the series MEDICAL ETHICS addresses the ethical, legal, methodological, and practical challenges arising from the Regulation regarding the development and use of medical devices.

In der synthetischen Biologie werden Methoden insbesondere der Molekularbiologie, der Ingenieurwissenschaften und der Informationstechnik miteinander verbunden. Ziel dieser Kooperation ist die Erzeugung von biologischen Konstrukten, die weder eindeutig der Kategorie eines naturlich gewachsenen Organismus noch der einer technisch geschaffenen Maschine zuzuordnen sind. Die synthetische Biologie wirft damit ethische und naturphilosophische Fragen auf und stellt zudem neue Anforderungen an die bisherigen rechtlichen Regelungen.