Health Technology Assessment

Health Technology Assessment (HTA) systematically evaluates the relative effectiveness, cost-effectiveness and economic, social and organisational impact of health technologies on the lives of patients, healthcare systems and society. The relative effects of a technology or solution are compared to current practices.

HTA reports aim to inform decision-making on, for example, appropriate use, clinical guidelines or national/regional funding.

MedTech Europe welcomes advances in the assessment of medical technology innovations, and the appropriate rewarding of the value these innovations bring. 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 certain instances, HTA can be used to assess a medical technology, for specific purposes, at specific times and to address specific country needs. This reflects the decentralised and localised market access model, well-suited for Member States’ decision-making.

*HTAi reference

MedTech Europe’s view on HTA

The fundamental guiding principles of HTA for medical technology and solutions in Europe today should be: clear purpose of HTA, transparency of the process, appropriate timing and adaptive evidence profile.

At a European level, cooperation in the field of HTA has been ongoing for years, through European joint action, and the HTA Network within the Cross-Border Directive in which MedTech Europe has actively participated. At the end of 2021, the Directive was replaced by a Regulation introducing newly defined cooperation in the field of HTA (HTAR).

Our team supports the creation of an appropriate policy environment and initiatives that:

• Promote timely access to and funding of innovation.
• Enable accelerated and equal accessibility of innovative technologies.
• Enhance the use of innovative technologies in healthcare delivery, to contribute to more sustainable and resilient national health systems.

The road ahead

MedTech Europe has been an active partner during the implementation of the regulation on HTA and will continue to be an active partner throughout its application phase. As a member of the Stakeholder Network, maintaining a strong voice involves: interactions with the European Commission, the Coordination Group on Health Technology Assessment (HTACG) and its respective subgroups, and engaging in a dialogue with the relevant stakeholders.

The Health Technology Assessment Regulation (HTAR) became applicable on 12 January 2025. In this context, MedTech Europe is setting a particular focus on the development of processes and fit-for-purpose methodologies and guidance.

In order to unlock the Regulation on HTA to create a favourable environment for medical technology innovation, we consider that the following principles are key:

• Creating opportunities for early dialogue with health technology developers and involvement of other stakeholders.
• Mitigating the risk for extra administrative burden.
• Increasing predictability of processes and timelines.
• Applying an adaptive approach for Joint Clinical Assessment (JCA) reports that comprehensively incorporate all available evidence sources and effectively inform national access pathways.

MedTech Europe’s overarching aim is to make the latest medical technology innovations available to European citizens while mitigating the risk of delays in access to technologies for patients and healthcare systems, an increased burden for the medical technology industry, and deprioritising Europe as a preferred market for innovation.

A community of experts

Building expertise and advancing the assessment of medical technology innovations

High-quality standards are needed in the assessment of the value of medical technology innovations along their lifecycle. To make this possible, MedTech Europe is committed to fostering the discussion on tailored and fit-for-purpose value assessment frameworks. We therefore have set up a community of experts focusing on:

Avenues to adapt HTA approaches

Our discussion paper has contributed to the current debate on high-quality standards in the implementation and adoption of methods and guidance on the EU Regulation on HTA. The paper seeks to explain what an adaptive approach is, why it matters, and how it can be applied in the context of the EU Regulation on HTA.

Avenues to advance the assessment of Digital Health Technologies

Our recent reflection paper highlights the need for comprehensive and adaptive evaluation frameworks for digital medical devices and reflects on ongoing country-specific initiatives and on approaches for EU-level harmonisation.