READ AND ACKNOWLEDGE

LEGACY MDT AGILE PG&C

Version 1.0

Legacy MDT Agile Product Governance and Compliance Module

Legacy Agile Product Governance & Compliance (PG&C) is a module being implemented in Legacy Agile to manage environmental product
and packaging regulatory compliance information. This tool connects environmental product and packaging compliance data to products
and/or components using existing BOM structures storage and retrieval for regulatory inquiries. A visual indicator shows compliance status
to the environmental product and packaging regulations such as EU MDR Hazardous Substances, EU RoHS 2, EU RoHS 3, China RoHS, EU
REACH, POPs, CA Prop 65, and latex.

This document will give an overview of the PG&C License and the screen changes due to the implementation of the PG&C Module.

PG&C License
All employees using Agile and have taken training will have a license. The default role for Agile PG&C is “Viewer.” For obtaining this, the
minimum amount of training is:
• Complete this Read and Acknowledge document
• Upon completion of this document, you will be assigned the role of “Viewer” for Agile PG&C

Roles in PG&C
The roles in PG&C are as follows
• Viewer
o Views part/product compliance status, evidence and Declarations
• Originator
o Creates/updates Declarations
o Contributes evidence to Declarations created by someone else
o Completes tasks related to Declarations
o Reviews Declarations
Agile PG&C Medtronic Confidential Page 1 of 6
 • Approver
o Approves or rejects Declarations
o Oversees that evidence is appropriate and complete
o Oversees adherence to processes
• Compliance Manager
o Subject Matter Expert (SME) for Declarations
o Ensures evidence is appropriate and complete
o Validates adherence to processes
• Administrator
o Creates/updates specifications and associated exemption reasons

For Phase One rollout, RTG: ENT will be assigning specific roles for their area. Users needing another role besides the default viewer, can
request this through their business unit.

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Screen Changes in Legacy Agile
Greater China, RCS, Spine, and CVG data models:
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BOM Tab
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• This is the base view sample

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ST and Diabetes data models:
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BOM Tab

Compliance Tab

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