Highlights from La Rentrée du DM 2025

The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global medical device regulation.

Main themes included:

• Updates on EU MDR/IVDR and new regulatory initiatives in France
• Structured dialogue with Notified Bodies and the harmonization of technical documentation
• Post-market discontinuation and the importance of anticipation for patient safety
• Eco-design and sustainability, bridging healthcare and environmental responsibility
• Software and AI in clinical investigations, and the use of real-world data
• Global market access – EU vs US pathways and MDSAP recognition
• Technical deep dives into ISO 13485, biocompatibility, usability, and cybersecurity

The consensus was clear: regulatory pressure is increasing, but collaboration, innovation, and anticipation remain the keys to success.

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
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