MDR & IVDR 2.0: The Post-Deadline Compliance & Audit Forum

The enforcement era of EU medical device regulation is here — and it just got more complex.

With the major MDR and IVDR deadlines now behind us, European manufacturers, importers, and distributors are navigating a new reality: heightened notified body scrutiny, unannounced competent authority audits, and the growing gap between technical submission and true operational compliance.

And now, a second regulatory wave is arriving before the first one is fully absorbed.

On May 7, 2026, the European Parliament and Council reached a political agreement on the “Digital Omnibus” package, confirming that medical devices and IVDs will remain subject to both the EU AI Act and MDR/IVDR in parallel. Unlike other industrial sectors that secured full exemptions, the medical device industry must now prepare for dual compliance — with a deadline of August 2, 2028 and harmonized guidance that does not yet exist.

For Regulatory Affairs and Quality Assurance professionals, 2026 marks a critical inflection point. EUDAMED registration demands are intensifying, post-market surveillance obligations are expanding, and many organizations are discovering that legacy processes built for the old MDD/IVDD framework are no longer sufficient. Now, the question of how to integrate AI Act obligations without duplicating MDR/IVDR compliance work is landing on the same desks — without a clear answer.

This senior-level forum brings together Regulatory Affairs Directors, Quality Assurance Managers, and Compliance leaders from Europe’s medical device and in vitro diagnostic industry to navigate these challenges together. Participants will exchange firsthand experiences from audit encounters, share practical approaches to post-market clinical follow-up, examine how leading manufacturers are restructuring their compliance operations for the long term — and collectively begin mapping the road to dual MDR/IVDR and AI Act compliance.

Beyond knowledge exchange, this forum creates a trusted space where practitioners can benchmark their approaches, stress-test their audit readiness, and build relationships with peers who understand the operational realities of post-deadline regulation. The peer-to-peer format encourages candid dialogue about real gaps, hard lessons, and proven fixes — helping your organization stay ahead of enforcement, avoid costly non-conformities, and prepare intelligently for what comes next.