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Methods for Health Technology Assessment of Medical Devices: a European Perspective

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To improve methods to assess medical devices

Policymakers, clinicians and the medical device industry increasingly demand sound evidence to support decisions about whether or how to introduce and adopt innovative health technology, and regarding its impact. An EU initiative advanced the state of the art in health technology assessment (HTA).


HTA supports the decision-making process with respect to technological innovations that are cost effective. Increased demand for HTA is urging the sector to develop more systematic and transparent assessment processes and to report to different stakeholders. However, current HTA methods do not completely take into account the fundamental differences that exist between various health technologies, especially medical devices. With EU funding, the MEDTECHTA (Methods for health technology assessment of medical devices: A European perspective) project set out to improve existing HTA methods in assessing medical devices. Work began by examining available evidence on current adopted approaches for the HTA of medical devices and international regulatory guidance on their licensing. To this end, project partners reviewed regulatory practices in the EU, the United States and five other countries, and conducted a cross-country analysis of HTA guidelines and available HTA reports on medical devices. In addition, the geographical disparity in medical device access in Member States was studied by analysing and explaining the different adoption rate of selected medical technologies in electrophysiology. The MEDTECHTA team developed an improved methodological framework for conducting HTA. They trialled the new methodological approaches on medical devices at various stages of development and diffusion within the healthcare system. Further to this, researchers explored different methods for economic assessment of medical devices currently adopted in Member States, the uncertainty in economic evaluation of medical devices compared to pharmaceuticals, as well as the organisational impact of medical devices. Lastly, recommendations were made to improve the HTA process, develop HTA methods and optimise the diffusion of medical devices. Thanks to MEDTECHTA, policymakers, the scientific community, HTA agencies, healthcare providers, the medical device industry and patients all stand to benefit from the development of optimised HTA methodologies and practices for medical devices.


Medical devices, health technology assessment, MEDTECHTA, healthcare

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