Regulatory Hurdles and Reimbursement in European Diagnostics Markets

Table of Contents

• 1. Executive Summary
  • 1. Executive Summary
    • 1. Executive Summary
• 2. Research Scope and Methodology
  • 1. Research Scope and Methodology
    • 1. Research Scope and Methodology
• 3. Introduction and Background
  • 1. Introduction and Background
    • 1. European Policies on the Regulations of In vitro Diagnostic Medical Devices
• 4. The Key Regulatory IVD Environment in Europe
  • 1. The IVD Directive
    • 1. Purpose of the Directive
    • 2. IVD Directive and Intended Effects in Key Actors
    • 3. Postmarket Surveillance
    • 4. The European Data Bank
    • 5. CE Marking
    • 6. Translation into Local Languages
    • 7. Symbols
    • 8. Labelling Solutions
    • 9. National Interpretations and Additional Requirements
    • 10. Impact of Regulations on the IVD Market
    • 11. Regulatory Challenges for the IVD Manufacturer in the European IVD Market
    • 12. Seeking Harmony
• 5. The Healthcare Plans
  • 1. Healthcare Plans and Reimbursement Issues
    • 1. Healthcare Plans
    • 2. Diagnostic Related Groups--The German Way
    • 3. Impact of the Diagnostic Related Groups on the European IVD Industry
    • 4. Impact of Diagnostic Related Groups on Rest of Europe
• 6. Towards the Future
  • 1. The Future
    • 1. Advantages and Disadvantages of Regulations
    • 2. The Next 10 Years
• 7. Key Regulatory Organisations and Industry Participants
  • 1. Key Regulatory Organisations and Industry Participants
    • 1. Key Regulatory Organizations and Industry Participants
• 8. Decision Support Databases
  • 1. Decision Support Databases
    • 1. Decision Support Databases