150$150.00 Form that provides classification criteria for the change as well as a decision tree for determination of substantial and nonsubstantial changes. 150 quantity + SKU: FRM029 Category: Form Related products UDI Implementation Plan Template-IVDR – $150 $150.00 + Marketing Specification – $150 $150.00 + Template, Manufacturing Assessment-MDR – $150 $150.00 + Complaint Trend Analysis Template-IVDR – $150 $150.00 +