Mastering IVDR in 2025: Challenges and Strategies Across the Full Compliance Spectrum

The In Vitro Diagnostic Regulation (IVDR) represents one of the most significant regulatory shifts in the EU for IVD manufacturers, and the changes coming into force in 2025 are especially critical. 

With the end of key transition periods, manufacturers must now comply with stricter requirements around risk classification, clinical evidence, post-market surveillance and technical documentation. 

Attendees of the webinar will learn about:

• Legacy Devices & Transition Periods (2025–2027) - How to manage extensions, maintain market access and keep your documentation audit-ready.
• Performance Evaluation & Clinical Evidence - How to handle legacy data, justify equivalence and know when a clinical performance study is truly needed.
• Risk Classification Challenges - Real-world examples of tricky classifications—like genetic tests and companion diagnostics—and how to navigate the gray zones.
• AI in IVDs - How machine learning is being regulated under IVDR, what performance evaluation looks like for AI-based diagnostics and how the EU AI Act fits into the picture.

Speaker: Anais Larry, IVDR Program Manager, Consumer Medical and Information Technologies, UL Solutions

We look forward to seeing you at the webinar!