Innovation in Medical Device - Are You ready for UDI? | Page 5

UDI compliance begins with a comprehensive assessment of
your organization’s readiness across four key areas:
Labeling
Labeling
Direct
Direct
Marking
Marking

Organizational
Awareness and
Alignment
Assess organizational
awareness of the
UDI ruling and
preparedness for
implementation
requirements
Align on goals and
expectations

Data and
Data and
Applications
Applications
Architecture
Architecture

Product Portfolio
Impact Assessment

Operations
Impact Assessment

Implementation
Planning

Identify the profile
of current product
offerings across
global channels

Align on Device
Identifier and
Barcoding standards
and strategies to
implement consisten tly
across enterprise

FDA Unique Device Identification (UDI) System

Evaluate Your Readiness Level

Assess completeness
and identify gaps

Assess timing and
volume of products
impacted by labeling,
packaging, DM and
database reporting

Assess DM impact
and technology
options, and products
exempted from
DM requirements
Identify current data
and application
architecture and the
sources for required
UDI database elements

Develop a highlevel roadmap for
UDI implementation,
including threads
and activities
for processes,
technology,
organizational
change and
program
management

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