UDI in the EU – A Preliminary Look

Bonus Material:

Participants will receive a PDF of the summary of UDI requirements in both the MDR and the IVDR.

Why Should You Attend:

The EU has made available the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) before the final versions come into effect. These regulations describe the EU approach for Unique Device Identification. The regulations raise many interesting issues as part of the implementation. For example, the regulations include the distribution chain in UDI. An Economic Operator includes the manufacturer, the importer and the distributor. Importers and distributors verify the manufacturer assigned a UDI. For some kinds of devices, the Economic Operator as well as Health Institutions must keep records of the UDIs they have supplied or received.

Production Identifiers identify the unit of device production and could include serial number, lot/batch number, Software identification, manufacturing date or expiration date. If the label has a lot number, serial number, software identification or an expiration date on the label, then it becomes part of UDI-PI. The manufacturing date does not have to be part of UDI-PI unless it is the only production identifier on the label.

The regulation has special consideration for specific device types such as implantable devices, procedure packs, configurable devices and software.

There is a database with twenty-two core data elements including device status (not placed on the market, recalled, Field Safety Corrective Action initiated), name and address of the manufacturer and if applicable, the authorized representative and the device risk class. The database structure and submissions methods are not yet available.

Areas Covered in the Webinar:

• Describe the role of UDI in the MDR and IVDR
• Explain the concept of an Economic Operator and the relationship to the UDI system
• Describe the label device label requirements associated with UDI
• Explain the EU database core elements
• Identify the requirements for specific device types
• Explain the ISO 13485:2016 requirements for UDI and how they might apply in the EU

Who Will Benefit:

• Regulatory Managers
• Design Engineers
• Product Managers
• Labeling Specialists
• Project Managers
• Quality Managers
• Quality Engineers

Daniel O Leary
President, Ombu Enterprises, LLC

Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; 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.

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