Innovation for Your Health


Regulatory Affairs

Regulatory frameworks define the interfaces between product, user and consumer. How much innovation is actually permitted in practice in the areas of medical technology and pharmaceuticals? In this sense, the task force on Regulatory Affairs is more than just an information platform. Members work actively to shape existing as well as coming regulatory conditions in a way that is achievable.

Goals and tasks

  • Establish a competent network for exchanging information about current regulatory topics
  • Work on commonalities and take a unified position early on
  • Act as a necessary link among interested people representing companies, research and education
  • Keep abreast of and contribute to German and European legislation
  • Actively exchange practical experience and cooperatively raise awareness

Upcoming topics

  • Tightening of requirements for the clinical evaluation of medical products
  • Scrutiny process versus approval – advantages and disadvantages
  • UDI – challenges for manufacturers of medical products and the supply chain
  • The future of cooperation between Notified Bodies and manufacturers

Working committee leader

Heike Wachenhausen, Wachenhausen Rechtsanwälte


Prof. Dr. Heike Wachenhausen
Wachenhausen Rechtsanwälte Partnerschaft mbB


  • Desitin

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