Lead partner
Type of activity

Core research objectives

  1. To map the methodology and process of HTA and how it is used in appraising medical devices in EU Member States, clearly distinguishing between different categories of devices;
  2. To advance the debate on the suitability of current HTA assessment tools across different categories of medical devices;
  3. To identify how the current HTA assessment tools can be modified or adapted across different categories of medical devices with a view to producing robust HTA methods for medical devices.

During the first two years of the project, WP5 has completed the following tasks:

  • Development of a taxonomic model for medical device categorisation, incorporating the elements of risk and role/functionality of device types and an additional distinction between the diagnostic or therapeutic nature of devices, crucial for HTA purposes. The model aims to:
    • highlight the applicability of existing device categorizations for HTA purposes
    • indicate if and how assessment tools for devices can and should be modified to achieve best results depending on taxonomic position
  • Validation of the taxonomic model: 740 HTA reports from 32 institutions evaluating 799 technologies were collected and classified according to the taxonomic model, which confirmed that the taxonomic model is plausible and useful

During third and final year of the project, WP5 completed the following tasks:

  • a more detailed analysis of selected reports from the collected HTA report sample to further map methodological approaches and highlight challenges identified
  • interviews with a targeted sample of institutions involved in HTA in Europe to supplement and elaborate on existing findings with a view of providing policy-oriented insights on best practice

Summary of conclusions
HTA of medical devices: how to group them, how to evaluate them — current status and perspectives

Principal Investigator: Professor Dr.med. Reinhard Busse

Full title Advancing and strengthening the methodological tools and policies relating to the application and implementation of Health Technology Assessment (HTA)
Project number 305983
CoordinationLSE Health
Consortium 13 partners

The research leading to these results has received funding from the European Community's Seventh Framework Programme FP7/2007-2013 under grant agreement No. 305983.