The Development of Medical Devices

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

Dirk Lanz­erath, Sebas­t­ian Graf von Kiel­mansegg, Joerg Has­ford

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.

Further Information

ISBN: 978-3-643-91260-2

Publisher: LIT-Verlag

Publication Year: 2020

Pages: 168

Language: English

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