EUDAMED mandatory in May 2026

Get prepared in February at Executive Lunch Event

Join osapiens, PTC, and Kalypso in February for an exclusive in-person executive lunch for U.S. MedTech manufacturers entering or selling into the EU. Gain practical readiness insights, avoid common pitfalls, and learn best practices from early submissions.

Starting May 28, 2026, use of the core EUDAMED modules becomes mandatory, including Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. For many manufacturers, this marks the point where EUDAMED shifts from a regulatory rollout to an operational system that must run reliably every day.

For new devices, registrations must be completed to maintain EU market access. Existing portfolios will enter a transition period extending through late November 2026. Additional modules, including Vigilance, are expected to become mandatory in 2027.

The real challenge is not the regulation itself—it’s execution. Manufacturers must prepare validated, submission-ready device data, align Regulatory Affairs, Quality, and IT, and coordinate effectively with external stakeholders such as Notified Bodies. When organizations start too late, timelines don’t just tighten; bottlenecks, rework, and last-minute exceptions emerge—putting EU market access and revenue at risk.

What you can expect:

A clear overview of the confirmed EUDAMED milestones and their practical impact
Insights into why data quality is the biggest challenge to EUDAMED compliance
Key steps to prioritize now: data assessment, early testing, and validated processes
Best practices from early EUDAMED submissions and implementation projects
How to build a scalable foundation for EUDAMED and global UDI readiness

To make participation easy, we’re hosting this executive lunch across three U.S. regions on three separate dates. Each session follows the same structured agenda and includes dedicated time for peer discussion and exchange.

Join osapiens, PTC, and Kalypso in February for an exclusive in-person executive lunch for U.S. MedTech manufacturers entering or selling into the EU. Gain practical readiness insights, avoid common pitfalls, and learn best practices from early submissions.

Starting May 28, 2026, use of the core EUDAMED modules becomes mandatory, including Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. For many manufacturers, this marks the point where EUDAMED shifts from a regulatory rollout to an operational system that must run reliably every day.

For new devices, registrations must be completed to maintain EU market access. Existing portfolios will enter a transition period extending through late November 2026. Additional modules, including Vigilance, are expected to become mandatory in 2027.

The real challenge is not the regulation itself—it’s execution. Manufacturers must prepare validated, submission-ready device data, align Regulatory Affairs, Quality, and IT, and coordinate effectively with external stakeholders such as Notified Bodies. When organizations start too late, timelines don’t just tighten; bottlenecks, rework, and last-minute exceptions emerge—putting EU market access and revenue at risk.

What you can expect:

A clear overview of the confirmed EUDAMED milestones and their practical impact
Insights into why data quality is the biggest challenge to EUDAMED compliance
Key steps to prioritize now: data assessment, early testing, and validated processes
Best practices from early EUDAMED submissions and implementation projects
How to build a scalable foundation for EUDAMED and global UDI readiness

To make participation easy, we’re hosting this executive lunch across three U.S. regions on three separate dates. Each session follows the same structured agenda and includes dedicated time for peer discussion and exchange.