The Development of Medical Devices Ethical, Legal and Methodological Impacts of the EU Medical Device Regulation

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.

Joerg Hasford is Professor at the Institute for Medical Information Processing, Biometry and Epidemiology at the Ludwig-Maximilians-Universität München, Munich, Germany. Dirk Lanzerath is Executive Officer at the German Reference Centre for Ethics in the Life Sciences (DRZE), Bonn, Germany and Secretary General of the European Network of Research Ethics Committees. Sebastian Graf von Kielmansegg is Professor and Chair of Public Law and Medical Law, Kiel University, Germany.