This episode details the critical EUDAMED deadline of May 28, 2026, when four key modules become mandatory for medical device and IVD manufacturers in the EU. We explain the immediate legal obligation to register all new MDR and IVDR devices in the UDI/Devices module before market placement. We also cover the mandatory registration for actors—manufacturers, authorized representatives, and importers—and the separate deadline of November 28, 2026, for registering legacy devices and uploading certificates.

- What is the critical EUDAMED deadline on May 28, 2026?

- Which four EUDAMED modules are becoming mandatory?

- What is the new legal requirement for all new MDR and IVDR devices before they can enter the EU market?

- Which economic operators must register in the Actor module?

- Is there a different deadline for registering "legacy devices"?

- What are the requirements for uploading certificates from Notified Bodies?

- How does this change impact your company's EU market access strategy?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. With the EU's EUDAMED deadlines approaching, our expertise in regulatory strategy and technical dossier submission is crucial. We act as your local representative and use advanced AI to efficiently compile and manage your UDI/Device and Actor registrations, ensuring you meet the May 28, 2026, mandatory requirements without delay. Let us help you navigate these complex changes and maintain your market presence. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.