New article lays framework for DMD evaluation in EU

An EIT Health-led article published in Nature gives guidance for classifying and evaluating digital medical devices across Europe.

A recent article published in Nature, Classification grid and evidence matrix for evaluating digital medical devices under the European Union landscape, marks a milestone in efforts to streamline the assessment of digital medical devices (DMDs) across the European Union. The publication is the result of collaborative work by the European Taskforce for Harmonised Evaluations of DMDs, initiated and coordinated by EIT Health.

Accelerating market access through a unified approach

Launched in 2022 by the Digital Health Delegation (DNS), the European Taskforce brings together experts across Europe to address a key challenge: the lack of harmonised evaluation criteria for digital medical technologies. Its goal is to offer practical tools that support faster, fairer, and evidence-based integration of these technologies into healthcare systems across the EU.

The publication directly supports the forthcoming EU Health Technology Assessment (HTA) Regulation, which from 2025 will introduce joint clinical assessments for high-impact health technologies. These efforts are designed to improve access to innovation for patients across Member States.

Two key tools to support harmonisation

The new publication introduces two core methodological resources for regulators, evaluators, and decision-makers:

• A European-wide classification grid for digital medical devices, based on their intended purpose, risk level, and usage method.
• An evidence matrix, detailing the types and levels of evidence required for evaluating safety, technical performance, and clinical effectiveness according to each device category.

A third component of the Taskforce’s work, currently in progress, will address socio-economic evaluation criteria for integrating DMDs into national healthcare systems.

The publication is co-edited by experts from leading European institutions including EIT Health, Inria, Università Cattolica del Sacro Cuore, French and Belgian health authorities, and others.

Read the full publication here.

Complementing progress through the EDiHTA project

This initiative aligns with the EDiHTA project, where EIT Health is a collaborating partner. Coordinated by the Università Cattolica del Sacro Cuore, EDiHTA brings together a multi-disciplinary consortium of 16 partners from 10 European countries for a 4-year Horizon Europe Research and Innovation Action. EDiHTA aims to create the first flexible, inclusive, validated and ready-for-use European HTA framework for digital health technologies. The project focuses on:

• Promoting a holistic approach involving all stakeholders for consensus building at national and European levels
• Defining a common terminology, harmonising and enriching existing HTA frameworks and creating an open repository with frameworks, guides, articles and HTA methodologies;
• Optimising assessment processes along the digital healh tehnology (DHT) life cycle;
• Following a multi-stakeholder, multi-domain and modular approach;
• Providing a validated and ready-for-use digital HTA framework for DHTs.

Within the EDiHTA project, EIT Health plays a key role in co-designing the framework with a focus on innovators, stakeholders, and policymakers. It also supports piloting, validation, and evaluation efforts in collaboration with the digital health technology community. Additionally, EIT Health leads education and training activities to drive adoption of the framework and advises on long-term exploitation strategies.

From innovation acceleration to CE marking and reimbursement readiness, EIT Health continues to provide end-to-end support for start-ups across the digital health ecosystem.

A European effort to foster innovation and equity

By leading collaborative projects like the European Taskforce and EDiHTA, EIT Health reaffirms its commitment to helping digital health innovations reach patients faster — while ensuring safety, effectiveness, and system-wide value.