REGTech Insights: Regulation or strangulation – MedTechs through medical devices regulation in a jam?

Medical technology is one of the growth sectors and showpieces of the German economy. But there are signs that this does not have to remain so: According to a new study [1], the industry is losing momentum and innovative strength. An excess of regulation could be one reason for this; in particular the Medical Devices Regulation, which has been in force since 2017, seems to have further aggravated the situation.

It leads to more complex approval and testing procedures, raises the regulatory hurdles overall – and thus burdens companies with additional costs and narrower scope for innovation. Stagnating figures for patent registrations and increased activities in the direction of company takeovers and partner search can be seen as indicators that the air is getting thinner for MedTechs, especially for the smaller and younger among them.

„We can certainly see that MedTechs are now struggling with the regulatory requirements“

, says Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions, confirming the trend statements of the study. “This also applies to the area in which we are mainly active, i.e. quality and compliance management. The increased demand for digital solutions makes it clear that new ways are being sought to better implement external requirements and get complexity under control.

And the fact that good regulatory intentions can become an innovation problem is particularly evident in young companies. It is not only the approval of new products that has become a feat of strength in the meantime, which places great demands, if not excessive demands, on young companies and start-ups; the ‘day-to-day business’ in quality management also offers sufficient opportunities for distraction from the essentials, i.e. innovations.

„We have reacted to this situation and developed a suitable offer for start-ups and small, young companies with our VENTURES programme“

, Kraemer adds. “And the experience with this is consistently positive: The fact that start-ups operate a digital quality management system is appreciated by the Notified Bodies – apart from the fact that it makes life much easier in everyday quality work. VENTURES promotes the early development of a digital management system for compliance and quality based on DHC VISION. Young companies and start-ups receive special conditions for a sustainable and scalable cloud solution with controlled processes such as SOP, TRAINING, CAPA, DEVIATION, COMPLAINT or CHANGE Management.


[1] dazu: Jürgen Stüber, Wirtschaftliche Chancen für Medizintechnik-Startups sinken (22.08.2019)