Fifteen-page gap analysis and audit tool to help ensure compliance with EU 2017/745 (MDR). The document goes line-by-line through the contents of the MDR in order to assess compliance. In addition, it lists corresponding MDD and MEDDEV requirements to help identify and understand changes brought by the MDR. Excel functions are incorporated to automatically calculate the total number of assessed gaps, total open gaps, total closed gaps, and percentage of gaps closed. This Microsoft Excel Worksheet [format *.xlsx] is perfectly formatted to produce professional online or printed output for management reviews, meetings, or presentations.