Change Analysis & Gap Assessment Template - Europe MDR 2017/745

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Two (2) Documents
- MDR vs MDD Change Analysis
- MDR Gap Assessment Template

Change Analysis (158 pages)
- Contains full text of the MDR and “MDR Wording Change Analysis vs MDD” for each element
- Includes color highlighting for keywords such as manufacturer, risk, risk management, label(ing), UDI

Gap Assessment Template (16 pages)
- Contains numbers and titles of all MDR chapters, articles, and annexes
- Provides framework for manufacturers to perform their own impact assessment