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The European medical device regulation (2017/745): saving lives or stifling innovation?
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| 2.19 MB | Adobe PDF |
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The demand for medical products is increasing. However, their manufacturing and application are subject to regulation and certification processes. The aim of this thesis is to discuss the development of this industry in the context of the new Medical Device Regulation (MDR). Expert interviews from production, medical law, the field of medicine, including the university environment, are qualitatively evaluated on the basis of the theoretical concept of the relationship between regulation and innovation. Agreements and controversies about the intentions of the MDR are captured and possible reactions to the changing European legislation are depicted.
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Medical device regulation Medical devices Health Innovation Germany