UL’S COMPLETE SERVICE OFFERING HELPS MANUFACTURERS ACHIEVE COMPLIANCE

On September 24, 2013, the U.S. FDA published a final rule requiring medical devices to have a Unique Device Identifier. Applicable products must comply with the tiered implementation deadline, established by device classification.  This requirement extends to device manufacturers selling and marketing products in the U.S., including manufacturers exporting to the U.S.

 

Complete service offering approach available

UL understands the impact of UDI on your company’s systems and provides a comprehensive solution to support UDI from beginning to end.  There are three interrelated elements to successfully implement UDI: Labeling, Informatics and Integration into your Processes and Procedures. Planning ahead allows you to identify internal resources, collect the appropriate data and make informed proactive decisions to ensure that your firm is fully prepared to meet these timely requirements.  UL can help your organization meet the challenge of UDI compliance with our advisory and support services.

Product Assessment:

  • Identify and prioritize products requiring UDI
  • Recognize and collect information needed for each product
  • Work with your staff to develop a project plan

Labeling Assessment: 

  • Review your current label artwork against the UDI requirements
  • Assess your label development methods for improvements in speed and efficiencies
  • Work with your staff to characterize the device identifier(s), product identifier(s), packaging level(s), etc.
  • Assist you in developing initial drafts of artwork revisions

UDI GAP Assessment: 

  • Create a comprehensive GAP Assessment
  • Examine current SOPs, processes & procedures needing modifications and (on request) identify potential improvements
  • Help you build a foundation to achieve compliance with FDA UDI requirements.

GUDID (Global Unique Device Identifier Database) submission and compliance: 

  • Discuss GUDID interface and submission.
  • Enter UDI data into the Global Unique Device Identification Database (GUDID).

  UDI Project Management: 

  • We offer knowledgeable Project Management resources to work with your staff as one team to execute a project schedule and minimize the impact to your resources.
  • Oversight and guidance to overcome obstacles during the effort

  Additional Support Services Provided by UL: 

  • Submission assistance (if needed) to an FDA-accredited issuing agency. (GS1, ICCBBA and HIBCC)
  • Support in barcode style selection targeted for use on the package labels and/or device itself
  • Development support for barcode quality, validation and traceability programs
  • Guidance on Supply Chain management and validation to support UDI implementation (as needed)

Find out more. Email: Medical.Inquiry@ul.com or call: +1-888-503-5537