12/10/2026
Regulatory Alignment as a Key Issue for International Medical Technology
At the 9th German–East European Health Forum in Berlin, representatives from politics, the healthcare sector, academia, and industry came together to discuss current challenges and new approaches for healthcare systems in Europe and Eastern Europe.
PHYSIOMED was represented at the event by Jan Schneider, CTO and Head of Regulatory Affairs & Quality Management, and Holger Terlohr, Senior Sales Manager International.
One of the central programme items was the panel discussion “European Cooperation for Resilient Health Systems: The Role of Regulatory Alignment”, in which Jan Schneider participated as a speaker.
Regulatory alignment is of major importance for internationally active medical technology companies. More harmonized and better coordinated regulatory requirements can facilitate market access, make processes more efficient, and help ensure that innovative medical devices become available more quickly across different markets.
At the same time, from the perspective of a medium-sized medical technology company, it becomes very clear how challenging the increasing regulatory complexity can be in practice. Different national requirements, extensive documentation and evidence obligations, as well as the associated demands on time, personnel, and financial resources, create significant challenges for manufacturers.
These challenges do not affect Regulatory Affairs alone, but have a direct impact on international market development: Which products can be offered in which markets? How quickly can new markets be entered? And how much effort is required to continuously comply with differing national requirements?
This makes an ongoing dialogue between industry, regulatory authorities, policymakers, and healthcare organisations all the more important. The objective must be to shape regulatory requirements in a way that maintains high standards of quality and patient safety while also enabling innovation, competitiveness, and international market development.
During the panel, Jan Schneider presented the perspective of a medium-sized medical technology company in a very clear, practical, and informative way, making an important contribution to the discussion.
A sincere thank you to the German Health Alliance, the German Eastern Business Association, and KPMG as host for the excellent organisation, the open exchange, and the many valuable conversations.
