Understanding Regulatory Requirements and Registration Practices for Medical Devices in Germany: Perspectives of Industrial Experts

Leonie Levin
Technische Universität München, Germany

DOI:https://doi.org/10.5912/jcb1527

Abstract:

The medical device industry in Germany is advanced and innovative. Moreover, it stands at the third position in the world in terms of volume and quality of medical device production in a year, as well as annual revenue generation from the industry. However, there is a lack of understanding regarding the regulatory requirements and registration practices that can be used by new entrants in the market for medical devices in Germany. Therefore, the current study aimed to analyze these processes from the perspective of industrial experts. The researcher conducted semi-structured interviews with five biotechnologists and five legislative managers working within the biotech industry in Germany. The findings include a discussion regarding regulatory requirements, the importance of regulatory practices, innovation in the medical device industry, and the registration practices for medical devices in Germany. In the future, there is a need to conduct any empirical and statistical analysis regarding the impact of regulatory requirements and practices, innovation, funding, and research and development on the success of the medical device industry in Germany.