European digital health organizations call for uniform evaluation framework for digital medical devices

More than 30 digital health organizations from seven EU member states have joined forces to send a signal to Brussels: A Europe-wide standardized assessment framework for digital medical devices is to apply from 2026. The signatories include industry associations such as the German Digital Healthcare Association (SVDGV) as well as start-ups from France, Germany and other EU countries. Their common goal is the rapid, safe and fair integration of digital therapies, AI-supported applications and remote monitoring solutions into European healthcare systems.

A patchwork quilt slows down innovation

The signatories' appeal is no coincidence. Although the EU has provided important impetus with projects such as the European Health Data Space (EHDS) and national digitalization programmes, the regulation of digital healthcare products remains fragmented. Differences in certification, approval and reimbursement lead to duplicate review processes and long waiting times for patients.

If we want European solutions to succeed globally, we need to remove barriers and speed up access.

Jens Nörtershäuser, Co-Founder and Co-CEO of Kranus Health

As a result, start-ups cannot easily transfer their innovations to other European markets. As a result, Europe is at risk of falling behind in international competition and losing its digital sovereignty.

Three recommendations for the EU

The declaration formulates concrete proposals on how the framework conditions for digital medical devices can be improved:

1. Uniform criteria: Development of common clinical and technical standards for digital therapies, remote patient monitoring and AI-supported products.
2. Harmonization of procedures: Reduction of regulatory differences in approval and reimbursement, especially between large markets such as Germany and France.
3. Clear timetables: Introduction of a system that ensures Europe-wide availability within two to three years of the first national approval.

This should create an environment in which start-ups can scale faster and patients have access to new solutions regardless of where they live.

Voices from the industry

Leading figures from the digital health scene emphasize the urgency:

• Hannes Klöpper, CEO of HelloBetter, calls for pragmatic regulatory solutions that enable manufacturers to introduce innovations across Europe in an uncomplicated manner.
• Anne Sophie Geier, Managing Director of the SVDGV, speaks of an "implementable proposal to bring European healthcare innovations to the masses".
• Maya Noël, CEO of France Digitale, believes that Europe's technological sovereignty is at risk if cross-border access is not created.

Political course must be set

The initiative of the digital health organizations ties in with recent political developments. There is a growing willingness in Brussels and the member states to promote cross-border cooperation and support European start-ups in scaling up. The evaluation framework that is now being called for would be a decisive step towards turning announcements into concrete results.

Whether a Europe-wide solution can be implemented by 2026 will largely depend on how quickly EU institutions and member states can agree on common standards. The topic is of central importance for founders in the digital health sector, as it will determine whether Europe plays a leading role in digital healthcare in the future.