Call for a pragmatic, convergent European evaluation framework for Digital Medical Devices

A huge digital health potential in Europe endangered by local fragmentation

With its 450 million citizens, the European Union (EU) faces numerous healthcare challenges, including an aging population, an increase in the prevalence of chronic illnesses, and a growing shortage of healthcare professionals(1).

A new generation of European digital health startups has already demonstrated its potential to address these challenges through robust clinical studies and technical certifications in their home markets. The adoption of their solutions is well-established among patients and healthcare professionals (HCPs). Hundreds of thousands of patients have already used remote patient monitoring (RPM) or remote therapeutic monitoring (RTM) in France, or digital therapeutics (DTx) in Germany, following a medical prescription. However, diverging evaluation frameworks across EU member states prevent these solutions from scaling from one country to another and from accessing sustainable economic models.

In the context of intense global competition and rapid technological advancement, this fragmentation threatens the survival of the European digital health industry and undermines the EU’s technological sovereignty. It also leads to unequal access for patients, healthcare professionals, and payers across Europe.

The urgent need for a convergent EU evaluation framework with common clinical and technical criteria

There is now an urgent need to establish a unified European evaluation framework based on pragmatic common clinical and technical criteria. Such convergence would not only enable the emergence of strong European players capable of competing globally but also safeguard Europe’s technological sovereignty.

This framework would also support the integration of digital health solutions into the upcoming European Health Data Space (EHDS). Without the widespread adoption of these solutions across the EU, the EHDS risks remaining as a theoretical construct with limited operational impact.

Bridging political vision and practical implementation

Encouraging steps have been taken at the political level to lay the groundwork for a common evaluation framework(2) , strengthen cross-border collaboration(3) , and support the scaling of EU startups across the continent(4) . These initiatives reflect a strong political commitment to advancing healthcare innovation in Europe.

The next crucial step is to translate this momentum into concrete outcomes – within timelines that are realistic and workable for European startups.

So far, early cross-border evaluations have revealed divergences in reimbursement decisions on digital medical devices (DMDs), even when based on identical clinical data. Differences in technical requirements across countries have also been observed. Both contribute to increasing delays and costs to reach European market access. There is a strong hope – and a clear need – for this situation to evolve quickly.

Our call as European Digital Health Innovators :

As a coalition of EU startups driving innovation in digital health, we call for the establishment of a pragmatic and convergent European evaluation framework – based on common clinical and technical criteria – starting in 2026.

Such a framework would enable the swift and efficient cross-border diffusion of healthcare innovations, drive massive investments within the digital health sector in Europe, while matching the pace of technological development.

The race for European Technological Sovereignty is happening now. We need access to a unified European digital health market – now.

 

Summary

• A new generation of European digital health startups has already proven its ability to address healthcare challenges with validated clinical outcomes, certified technologies and adoption by patients and HCPs.
• However, fragmented evaluation frameworks across EU member states hinder cross-border scaling.
• This fragmentation threatens the short-term viability of Europe’s digital health ecosystem and the EU’s technological sovereignty.
• Recent political initiatives have demonstrated an intention to converge on evaluation frameworks.
• Yet in 2025, real-world assessments of DMDs show that such convergence has not been achieved in practice.
• A pragmatic, unified EU evaluation framework must be implemented in 2026 to support the growth of European digital health startups and safeguard European technological sovereignty.

 

Next Steps

Starting in 2026, particularly in France and Germany, the 2 largest healthcare markets in Europe, we urge alignment on:

• Technical requirements for DMDs certification
• Clinical evaluation criteria for Digital Therapeutics (DTx), Remote Patient Monitoring (RPM), Remote Therapeutic Monitoring (RTM) and AI-powered health solutions
• Operational procedures and methodologies for DMDs reimbursement pathways

We also call for the future European evaluation framework to be truly pragmatic, ensuring that healthcare innovations can access the EU-wide market within a reasonable timeframe (2 to 3 years maximum) after their launch in their home country. Beyond this timeframe, such technologies risk becoming obsolete.

To achieve this short-term goal by 2026, we encourage European policymakers to adopt a pragmatic and resultsoriented approach. The lessons learned from HTA initiatives to harmonize the evaluation of other health products, which have led to a ratcheting up of requirements and delays in patient access, should be carefully considered.

The goal is to ensure that safe DMDs reach patients as soon as possible.

Signatories as of 25/08/2025 :

Industry associations:

Frédéric Girard, France Biotech

Marianne Tordeux Bitker, France Digitale

Guirec Le Lous, MedTech in France

Anne Sophie Geier, Spitzenverband Digitale Gesundheitsversorgung (SVDGV)

 

Companies:

Matthieu Lamy, Ad Scientiam

Guillaume Ploussard, AIMED2

Boris Lévêque, Axomove

Felix Köhler, Cara Care

François-Guirec Champoiseau, Cureety

Stanislas Niox-Chateau, Doctolib

Nadine Rohloff, Endo Health GmbH

Fabien Watrelot, ENSWEET

Emeline Hahn, Fizimed

Stan Sugarman, GAIA AG

Hannes Klöpper, HelloBetter

Arnaud Rosier, Implicity

Manuel Thurner, Kaia Health

Alexia Adda, Klava

Jens Nörtershäuser, Kranus Health

Pierre-Camille Altman, MDHC

Felix Lambrecht, MEDICE – The Health Family

Tom McCartan, Nazata Bio

Ludovic Ampe, Neuroventis

Jean Guillemain d’Echon, NEWCARD

Edmund Farrar, Oto

Kai Eberhardt, Oviva

François Vonthron, Poppins

Jonathan Benhamou, Resilience

Henrik Emmert, Sidekick Health Germany

Jukka Laakso, Soihtu DTx

Jakob Futorjanski, Synaptikon GmbH / NeuroNation MED

Edouard Gasser, Tilak Healthcare

Philip Heimann, Vivira Health Lab