Understanding UDI in EU Device Regulations – Webinar Recording/Transcript
Understanding UDI in EU Device Regulations
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.
- 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.