Understanding UDI in EU Device Regulations – Webinar Recording/Transcript

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Understanding UDI in EU Device Regulations

Want to attend the live webinar on Nov. 21? Click here to register.

EU device regs are an ongoing compliance headache but one thorny issue — UDI compliance deadlines for Class I and unclassified devices — is upcoming. When next May rolls around, will you be ready?

FDAnews has called on Dan O’Leary, master interpreter of complex device and diagnostics regulation, to untangle UDI’s complexities while there’s still time to prepare.

Join Dan for a 90-minute crash course in unique device identification (UDI) compliance. You’ll welcome this timely help: The EU system differs from FDA’s in significant ways.

Presentation Takeaways:

  • Overview of the EU’s UDI system
  • Requirements for devices and packages
  • The Basic UDI-DI: Its role and uses
  • EU-MDR Article 120 transition requirements
  • The European UDI workaround
  • EU-MDR database elements
  • EU-IVDR database elements
  • Database translation issues

BONUS: Receive an Excel workbook to help identify the database elements and verify the requirements.

Data elements ... verifying correctness and update labels ... translating and loading the database. No question: UDI compliance requires a team effort. Take this moment to ready your team for this compliance challenge.

  • Regulatory Affairs
  • Quality Assurance
  • Production Managers
  • Production Engineers
  • Data Analysts
  • Postmarket Safety
  • Submissions & Approvals
  • Commercial Operations

Meet Your Presenter
Dan O’Leary, one of FDAnews’s most sought-after presenters, is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has more than 30 years experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.