After years of anticipation and multiple delays, the European Commission has officially activated the first four EUDAMED modules—Actor Registration, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance. This long-awaited milestone, published during the U.S. Thanksgiving holiday in the Official Journal of the European Union (OJEU), sets the regulatory clock ticking.
With timelines now in motion and compliance requirements coming fast, medical device and IVD manufacturers must move quickly to align with the evolving MDR and IVDR ecosystem. These modules are not just technical milestones—they are strategic inflection points for digital quality and audit readiness in the EU market.
Watch USDM Life Sciences' Jay Crowley for a timely session on how to operationalize this major regulatory shift. We'll break down what’s live, what’s coming next, and how your organization can stay ahead of compliance timelines with a future-ready approach.
What You'll Learn:
- What the OJEU notice activates—and what it doesn’t (yet)
- Key deadlines, risks, and readiness steps for each EUDAMED module
- The role of digital compliance strategies and content harmonization
- How USDM can accelerate your EUDAMED readiness through trusted, tech-enabled support