Exploring the future of medical device and drug combination products: insights from EMA and key considerations for MR and MDR compliance

  • Understanding the increasing trend of combining medical devices and drugs
  • Gaining insights from the European Medicines Agency (EMA) on the future of medical device and drug combinations
  • Explaining the distinction between Medical Devices Regulation (MDR) and Medical Devices Directive (MR) for combination products
  • Identifying compliance requirements and implications based on the device’s primary mode of action
  • Presenting various regulatory pathways available for combination products
  • Understanding how partnerships can drive innovation and development in this domain