Will the EU HTA Regulation Boost or Slow Down MedTech Innovation?

The European Union’s new Health Technology Assessment Regulation (HTAR) is one of the most important changes currently affecting the MedTech industry.
The regulation officially became applicable in January 2025 and introduces permanent cooperation between EU Member States on selected elements of Health Technology Assessment. The first Joint Clinical Assessments (JCAs) for high-risk medical devices are expected to begin in 2026. (European Commission)
For MedTech companies, the central question is simple: will this new system make market access easier, or will it create even more complexity?
Why the EU Introduced the HTA Regulation
Historically, companies launching medical technologies in Europe have often faced multiple national HTA processes for the same product.
Different countries may ask for different evidence, use different comparators, and reach different conclusions about the value of a technology. This can be expensive, time-consuming, and particularly difficult for smaller MedTech companies. (MedTech Europe)
The goal of the new regulation is to reduce duplication by creating a more coordinated approach.
Instead of repeating the same clinical assessment in multiple countries, a Joint Clinical Assessment could provide one shared evaluation that Member States can later use in their own reimbursement and procurement decisions. Pricing, reimbursement, and funding decisions will still remain national, but the clinical review may only need to happen once. (MedTech Europe)
How the Regulation Could Support Innovation
In theory, the new system could benefit MedTech innovation in several ways.
First, it could reduce the need for multiple separate clinical submissions across Europe. For companies developing innovative technologies, especially startups with limited resources, this could lower costs and reduce duplication. (MedTech Europe)
Second, the new Joint Scientific Consultations (JSCs) may help developers understand evidence expectations earlier in the development process. These consultations allow companies to engage with HTA bodies before market entry and receive advice on the type of data they may need later. This can help companies generate stronger evidence from the beginning and avoid costly mistakes. (MedTech Europe)
Third, a more predictable HTA environment may make Europe more attractive for investment. Investors are increasingly interested in companies that have a clear pathway not only to regulatory approval, but also to reimbursement and adoption.
Why Some Companies Are Concerned
Despite these potential benefits, there are also concerns that the new system could create additional complexity rather than reduce it.
Medical devices are very different from pharmaceuticals. Devices often change rapidly, may be updated frequently, and are usually supported by different types of evidence. HTA bodies have traditionally had more experience assessing medicines than medical devices, which may create challenges when applying standardised assessment methods to MedTech products. (MedTech Europe)
There are also concerns about timing.
The early experience with the new HTA process suggests that evidence preparation timelines may be tight. For example, there can be only a short window between defining the Population, Intervention, Comparator, Outcomes (PICO) framework and submitting the final dossier. Companies may need to prepare evidence much earlier than they are used to. (ICON plc)
In addition, companies are already dealing with other major regulatory pressures, including the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and new transparency requirements linked to EUDAMED. For many MedTech companies, especially smaller firms, adding another layer of HTA requirements may feel overwhelming. (qservegroup.com)
Startups May Feel the Pressure Most
Large MedTech companies often have dedicated market access, HEOR, and regulatory teams. Smaller companies and startups usually do not.
This means startups may struggle more with:
• Building evidence strategies early
• Managing HTA submissions
• Coordinating between regulatory and reimbursement planning
• Understanding country-specific payer expectations
• Responding to new data requirements
At the same time, startups may also benefit the most from a more harmonised European system if it successfully reduces duplication.
For smaller companies, a single clinical assessment that supports multiple markets could be far more manageable than navigating several national processes independently.
What MedTech Companies Should Do Now
Whether the HTA Regulation ultimately boosts or slows innovation may depend largely on how companies prepare.
MedTech developers should begin:
• Planning HTA strategy earlier
• Generating stronger clinical and economic evidence
• Thinking carefully about comparators and outcomes
• Understanding payer expectations from the beginning
• Using Joint Scientific Consultations where possible
• Coordinating regulatory, reimbursement, and market access activities
The companies that adapt early are likely to be in a stronger position as the new system expands.
Conclusion
The EU HTA Regulation has the potential to make market access more efficient and predictable for MedTech companies. However, it may also increase evidence requirements and create new administrative challenges.
For now, the regulation is likely to do both.
Companies that prepare early, understand the new processes, and build stronger evidence strategies may benefit from a more harmonised system. Those that wait too long may find themselves facing greater complexity than before.