Regulatory Hurdles and Reimbursement in European Diagnostics Markets

Regulatory Hurdles and Reimbursement in European Diagnostics Markets

 

RELEASE DATE
19-Nov-2005
REGION
Europe
Research Code: B731-01-00-00-00
SKU: HC01164-EU-MR_05242
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$3,950.00
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HC01164-EU-MR_05242
$3,950.00
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Description

This strategic analysis service provides a detailed analysis of Regulatory Hurdles & Reimbursement in European Diagnostics. The service focusses on The Key Regulatory IVD Environment in Europe, healthcare plans and the future of regulations. .

Table of Contents

Introduction and Background

  • European Policies on the Regulations of In vitro Diagnostic Medical Devices

The IVD Directive

  • Purpose of the Directive
  • IVD Directive and Intended Effects in Key Actors
  • Postmarket Surveillance
  • The European Data Bank
  • CE Marking
  • Translation into Local Languages
  • Symbols
  • Labelling Solutions
  • National Interpretations and Additional Requirements
  • Impact of Regulations on the IVD Market
  • Regulatory Challenges for the IVD Manufacturer in the European IVD Market
  • Seeking Harmony

Healthcare Plans and Reimbursement Issues

  • Healthcare Plans
  • Diagnostic Related Groups—The German Way
  • Impact of the Diagnostic Related Groups on the European IVD Industry
  • Impact of Diagnostic Related Groups on Rest of Europe

The Future

  • Advantages and Disadvantages of Regulations
  • The Next 10 Years

Key Regulatory Organisations and Industry Participants

  • Key Regulatory Organizations and Industry Participants
This strategic analysis service provides a detailed analysis of Regulatory Hurdles & Reimbursement in European Diagnostics. The service focusses on The Key Regulatory IVD Environment in Europe, healthcare plans and the future of regulations. .
More Information
No Index Yes
Podcast No
Industries Healthcare
WIP Number B731-01-00-00-00
Is Prebook No