About VDE Health

VDE Health is the VDE’s strategic business unit dedicated to regulatory issues in medical technology. We identify relevant regulatory topics and provide support in accurately understanding, interpreting, and implementing regulatory requirements.

In doing so, we build on the strengths of an organization that has stood for technical safety, quality, and trust for more than 130 years. The VDE combines expertise in standardization, testing, certification, technology assessment, and regulatory matters. VDE Health helps to thoroughly analyze complex regulatory requirements for medical technologies, make knowledge accessible, and reduce regulatory barriers to innovation.

What sets us apart: VDE Health is backed by an extensive professional network of experts from various disciplines. Depending on the topic and task at hand, we can draw on expertise in the fields of medical devices, software and AI, cybersecurity, quality management, clinical evaluation, international regulation, standardization, and testing and certification.

Why VDE Health?

Understanding Regulatory Issues Across Disciplines

Today, regulatory requirements are linked across across many disciplines. The MDR, IVDR, quality management, standards, software, cybersecurity, AI regulation, international market access pathways, and post-market requirements must all be considered together.

VDE Health identifies and shares expert knowledge on regulatory issues throughout the entire product lifecycle—from regulatory strategy, through quality management and proof of conformity, to market access and post-market requirements. In addition, VDE Health offers technical and regulatory support in interpreting and implementing relevant requirements.

The goal is not to examine individual issues in isolation, but rather to analyze regulatory interrelationships from a technical perspective and to sustainably strengthen the regulatory capacity of professional communities.

Trust through experience and independence

The VDE is one of the leading organizations in the field of technical safety and compliance. Our work is characterized by technical expertise, objectivity, and high quality standards.

Industry experts rely on the expertise of VDE Health to assess regulatory issues from a technical perspective, identify regulatory challenges early on, and develop appropriate courses of action.

Expertise for Complex Challenges

Modern medical devices combine medicine, software, artificial intelligence, electronics, data processing, and international regulatory requirements. The challenges they present are correspondingly complex.

VDE Health serves as a platform for interdisciplinary exchange with external experts and relevant professional communities. This brings together knowledge from various disciplines and makes it accessible for the technical analysis of regulatory contexts.

International Perspective

Medical devices are developed for international markets. That is why VDE Health does not view regulatory requirements solely from a European perspective.

Whether it’s European CE marking, international market access requirements, FDA requirements, UKCA, or global quality management systems—VDE Health provides expert support in assessing the regulatory requirements of international markets at an early stage and developing appropriate approaches.

Our aim

We help ensure that regulatory requirements are viewed not merely as obstacles, but as the foundation for safe and compliant innovations.

Drawing on the VDE’s experience, professional network, and technical expertise, we help to better understand regulatory contexts, identify challenges early on, and design development and compliance processes based on sound technical principles.

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