Welcome to our MeetUp: "New EU medical device legislation – more supply security, less patient safety?"
The European Commission has put forward its proposals to revise the EU medical devices legislation. The objectives are clear: Reducing unnecessary burdens, accelerating procedures and improving the availability of medical devices in Europe.
Yet the central question remains: Can these objectives truly be achieved together, or does simplification risk coming at the expense of patient safety?
Several proposed changes touch the very core of Europe’s medical device safety framework – from classification rules and well-established technologies to surveillance mechanisms and unannounced audits. The discussion will therefore focus on how Europe can improve supply security while preserving the safeguards needed to ensure that patients and users remain effectively protected.
📅 Date: Wednesday, 1 July 2026
⌚ Time: 9:00–10:00 CEST
📍 Location: Online
🌐 Language: English
What level of oversight is needed to ensure safe and well-performing medical devices? How can Europe avoid unnecessary burdens while maintaining trust in its regulatory system? And where should the line be drawn between faster market access and patient safety?
This TÜV MeetUp brings together decision-makers and experts from EU institutions, manufacturers, consumer protection, and conformity assessment to discuss these important questions.
Speakers include:
• Tiemo Wölken, Member of the European Parliament and shadow rapporteur
• Julia Steckeler, Managing Director, Medical Mountains
• Ancel-la Santos, Head of Food, Health and Chemicals Safety, BEUC
• Royth von Hahn, Senior Vice President Medical & Health, TÜV SÜD