Will the EU Health Technology Assessment Regulation boost medtech innovation?

Once a new health technology is approved by regulators for safety and efficacy, it can be utilised by doctors or patients. However, regulators are not responsible for decisions regarding its purchase or reimbursement. Health Technology Assessment (HTA) assessors pose different questions compared to those asked by regulators. HTA evaluates whether a technology provides added value compared to existing products, guiding budget decisions made by national or regional authorities.

Assessing the value of a technology for HTA involves examining its clinical and socioeconomic aspects, including cost, usage, and impact on patients and health systems. This process requires data and communication between developers and HTA bodies and can be complex and lengthy, sometimes requiring the generation of new data.

Ever closer cooperation?

Developers introducing technologies in Europe often face multiple assessments for the same product, leading to varied data requests and differing conclusions by national HTA bodies. To improve efficiency and predictability, efforts have been made to increase EU-level cooperation. The European Commission highlighted HTA as a priority in 2004, which led to the creation of the EUnetHTA project and subsequent joint actions.

Now, more than 20 years later, a Regulation on HTA aims to formalise cooperation on some elements of the process. The HTAR has been applicable since January 2025, with key elements of collaboration beginning later this year and next year.

The big question for all concerned is: will it work?

Will the Regulation enhance efficiencies that promote innovation in the EU? Or could it increase the complexity of the process, potentially hindering the development or implementation of health technologies?

What exactly will change under the HTAR? 

The HTAR will not suddenly harmonise HTA processes across Europe. It will, however, seek to streamline a key element of how technologies are assessed. The Regulation provides a basis for permanent cooperation at EU level on Joint Clinical Assessment (JCA) for a selective group of highly innovative medical devices and in vitro diagnostics.

The idea is that, to avoid duplication of effort, a single JCA will be conducted, on which Member States can base their conclusions about pricing, reimbursement or procurement. Key decisions will still be made at national level, but a comprehensive clinical review would be conducted once. This, remember, is an alternative to having multiple national clinical assessments.

The EU-level JCAs are expected to begin in 2026. The HTAR also provides for Joint Scientific Consultations (JSCs) which will begin this year. JSCs allow developers to seek advice from authorities early in the development lifecycle to help them begin collecting the kinds of data that are likely to be needed later in the HTA process.

What’s next?

The implementation phase of the HTAR ended in January 2025. However, the field of ‘health technologies’ is a diverse one, and not all product types are at the same stage of readiness when it comes to implementation.

The pharmaceutical sector has significant experience in HTA and is already more advanced in adapting to the HTAR. The flipside of this is that HTA bodies are more familiar with assessing medicines than they are with evaluating devices or diagnostics.

Medical technologies are distinct from pharmaceuticals. Only specific categories of medical devices and diagnostics qualify for JCA. The exact timelines for applying JCAs to medtech are currently undefined, but a consultation is expected soon, providing opportunities to navigate this step collaboratively.

Developers and authorities will need to discuss the optimal timing in the development process to conduct a JCA, whether JCAs will be updated based on post-launch data, and whether it will be advantageous for innovative technologies to undergo a JCA.

Dialogue is crucial at this stage of the process. Stakeholders should consider how JCAs can be adapted to fit the characteristics of specific devices and the context in which they are used.

The overarching aim of these discussions is to promote stability and predictability within Europe’s medical technology sector. The upcoming MedTech Forum session will provide a platform for speakers to discuss the future of EU collaboration on HTA and its potential to introduce new solutions that deliver value to patients and health systems.