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case studiy medical device com3 1The Ask:

A global medical devices company wanted to embark on the implementation of the EU MDR.


  • 250+ Technical Files
  • Seven global locations

Results and Benefits

  • Project teams traceable to the EU MDR 2017/745 – MDR “To Do” list
  • Easy, live tracking and management of the Global EU MDR program
  • Global EU MDR program successfully moved to stable execution
  • 87 Project teams initiated, planned, and moved into successful execution
  • 233 Project team members engaged and mobilised
  • Standardised toolkit utilised & knowledge sharing leading to reduced planning phase
  • Global governance structure & communication plan Implemented
  • Graphical toolkit utilised to facilitate remote & group collaboration
  • 8 Months – Start to execution phase for 87 project teams


  • Very little internal experience in large scale programme management
  • The organisation did not have the experience to bring a global programme of this scale through the required phases and into execution
  • ‘No internal’ toolkit to address a programme of this scale
  • To move a program of this scale required a distinct set of tools that were standardised, scalable and transparent
  • How to measure & track progress over the programme lifecycle? (4 Years)
  • Overloaded Internal Staff: How can we make this management as hands-free as possible?


  • EU MDR will be legally binding
  • Products not compliant to EU MDR will no longer be saleable in the European Union
  • Annual sales in excess of $300 Million at risk
  • Significant hit to the global organisation bottom line


  • Traceability from the project team scope to the EU MDR Regulation
  • Governance model & program structure standardised & scalable across seven global sites
  • Reduce the management burden of the program as internal staff are heavily loaded
  • Capability for live accurate transparent measurement of progress
  • Bring the program to stable execution before transition
  • Transition: Hand over the management of the program to the internal team

The Approach:

eu mdr case study


  • Explic8 EU MDR Gap Assessment Template
  • Explic8 Work Breakdown Structure Template
  • Explic8 EU MDR Status Report
  • Explic8 EU MDR Progress & Compliance Tracking Database