#Rethink Medical Technology Meets Regulatory Affairs: A Closer Look

Between Medical Device Regulations and the Green Deal: Scope for Action on Sustainable Medical Devices

The demands on medical technology are increasing: On the one hand, strict medical technology regulatory requirements apply, with a focus on patient safety, clinical evidence, and quality management. On the other hand, the pace of sustainability regulations is noticeably accelerating—with implications for material use, packaging, product design, documentation, and end-of-life management.

In practice, this gives rise to intersections, conflicting goals, and trade-offs:

• How can material substitutions for better environmental performance be reconciled with biocompatibility, validation, and patient safety?
• Where do requirements for sterility, single-use products, and traceability conflict with circular economy approaches?
• What changes are possible without triggering regulatory issues?

This event provides guidance on relevant EU regulations and helps clarify typical areas of conflict. The focus is on sharing experiences: Which strategies are already working in companies—and where are new solutions needed?