Our Priorities Access to Medical Technology

Health Technology Assessment

assistance female doctor point and show Advanced medical equipment vital sign monitor display in hospital operation surgery room ward health concept

Health Technology Assessment (HTA) is the systematic evaluation of the relative effectiveness, cost-effectiveness and economic, social & organisational impact of health technologies on the lives of patients, health care systems and society. HTA looks at the relative impact of a technology or solution compared to the current standard of care.

HTA reports aim to inform decision-making on, for example, appropriate use, clinical guidelines or national/regional financing. HTA is only used to assess a medical technology in limited cases, for specific purposes and at specific times and implemented to address the specific country needs. This reflects the decentralised and localised market access model, well-suited for Member States’ decision-making on healthcare delivery.

For more than 10 years, in Europe, cooperation on HTA has been driven by HTA Agencies via the EUnetHTA platform and more recently by Member States participating in the HTA network under the Cross-Border Directive.

MedTech Europe supports timely access to innovation beneficial to patients and citizens, while helping to steer health systems onto a sustainable path.

MedTech Europe’s view on HTA can be found here for medical devices and here for IVD. The assessment of the value of medical technologies should take place using tools that are appropriate to the nature of the sector and its innovation model.

In our view, in certain circumstances, HTA might be of value if it:

  • focuses on transformative technologies;
  • is conducted with the appropriate methodology;
  • aims to answers the questions of Members States' decision makers; and
  • ultimately truly impacts funding, reimbursement or use, justifying investment in transforming health systems

While decision-making remains at Member States level, HTA cooperation for medical technologies across Europe is discussed. Cooperation could be of value for the identification of common unmet needs. It may also support the identification of technologies that might be of value (horizon scanning) to address unmet health and health system needs and in assessing their value and value for money. HTA should also monitor implementation in practice.

MedTech Europe works closely with EU institutions and other stakeholders to make sure that the specificities of medical technologies and market access pathways are recognised, and that HTA and HTA cooperation are made fit-for-purpose. MedTech Europe aims to make the latest medtech innovations available and to mitigate the risk of delays in access to technologies for patients and healthcare systems; of an increased burden for the medtech industry without benefit; and of putting at risk Europe’s position as a preferred market to innovate.

Our team supports an appropriate policy environment to foster the development of, and access to, innovative and valuable medical technologies. We work to ensure the value that our technologies and solutions bring to patients, society and health systems is adequately recognised and incentivized.

MedTech Europe is engaged with EUnetHTA JA3 and is an observer at the European HTA Network. We contribute to European research initiatives and engage at HTA International (HTAi) and other conferences. MedTech Europe is also active to provide the MedTech industries views of the EU HTA Regulation.