Digital Medical Devices (DMDs) are playing an increasingly important role in healthcare across the European Union, offering new ways to prevent, diagnose and manage conditions. However, their integration into national health systems remains inconsistent. Varying national frameworks, classification schemes and evidence standards have created a fragmented landscape. This lack of harmonisation hampers the ability of developers to navigate approval processes and of healthcare systems to evaluate and adopt new technologies efficiently. In response, a European Taskforce has developed two complementary tools: the Common European Classification Grid for Digital Medical Devices (CEUGrid-DMD) and the Evidence Matrix. Together, they aim to standardise how DMDs are categorised and assessed, supporting alignment across the EU and accelerating access to beneficial innovations.
A Common Language for Diverse Technologies
The CEUGrid-DMD provides a structured framework to classify digital medical devices according to their purpose and mode of use. It introduces five main categories—Inform, Diagnose, Manage, Monitor and Treat—based on a device’s primary function. Each category is further subdivided according to the intended beneficiary, whether it is the patient or a healthcare professional, and whether the device is used independently or as part of an integrated care pathway.
By clearly defining inclusion and exclusion criteria, the CEUGrid-DMD distinguishes medical-purpose technologies from general wellness applications. It also ensures coherence with the EU Medical Device Regulation (2017/745), focusing on CE-marked technologies that use digital methods to support prevention, diagnosis or treatment. Devices covered range from AI-based diagnostic aids and self-monitoring tools to digital therapeutics and remote monitoring platforms.
The grid’s structured taxonomy helps reduce ambiguity in the classification of digital tools, which is a key challenge for developers and assessors alike. National bodies in Germany, France and Belgium, for instance, have each adopted different schemes in their DMD evaluations. The CEUGrid-DMD aims to align such systems, enabling developers to map their products onto a common reference and easing transposition into national procedures. In doing so, it promotes a more consistent and transparent approach to classification throughout the EU.
Clarifying Evidence Expectations for Developers and Assessors
In parallel with classification, the Evidence Matrix sets out the types of information and evidence required to evaluate a DMD. It combines traditional domains from the EUnetHTA Core Model—such as clinical efficacy, safety, economic impact and organisational relevance—with domains tailored to digital technology. These include data security, interoperability and technical performance, especially where artificial intelligence is involved.
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For AI-enabled DMDs, the matrix addresses specific issues such as model validation, algorithmic robustness and explainability. It also recognises that new kinds of clinical evidence may be acceptable, including adaptive trial designs, single-arm studies and real-world evidence. This flexibility reflects the evolving nature of digital technologies, which often do not fit neatly into traditional clinical trial models.
Input from ten HTA bodies across nine EU countries confirmed the value of a common structure for evidence requirements. While clinical effectiveness remains the most consistently assessed domain, social, ethical and environmental aspects are often overlooked. The Evidence Matrix helps fill these gaps and offers a tool for planning evidence generation aligned with future regulatory and reimbursement expectations.
By guiding developers on what data to collect and how it will be assessed, the matrix reduces uncertainty, supports earlier engagement with HTA bodies and improves the likelihood of market access. It also provides a resource for national agencies to benchmark and refine their own assessment procedures, particularly in countries where DMD-specific frameworks are still being developed.
Laying the Groundwork for European Collaboration
Although some EU Member States such as Germany, France and Belgium have implemented funding and evaluation pathways for DMDs, most others remain in early stages of policy development. The CEUGrid-DMD and Evidence Matrix provide tools for voluntary collaboration, supporting knowledge sharing and joint assessments.
The Health Technology Assessment Regulation (HTAR), which took effect in January 2025, offers a legal basis for such collaboration. Although DMDs are not a mandatory focus under this regulation, Article 23 permits voluntary cooperation. The classification and evidence tools align with this framework and have already been adopted by EU-funded projects such as EDiHTA and ASSESS DHT, which seek to develop standard methodologies for assessing digital health technologies.
These projects aim to incorporate real-world data and patient-reported outcomes into decision-making processes. As part of this broader digital health ecosystem—including the European Health Data Space—they reinforce the need for coherent, evidence-driven approaches to technology integration. The classification grid and matrix are already supporting these efforts by providing a basis for consistent and transferable evaluations.
Nevertheless, national differences in healthcare organisation, data protection regimes and evaluation practices remain significant challenges. Some countries assess digital aspects like cybersecurity and interoperability outside of their HTA bodies, while others include these within their assessments. Despite these limitations, the new tools represent an important step towards establishing shared principles and fostering mutual understanding across the EU.
The introduction of the CEUGrid-DMD and the Evidence Matrix marks a major advance in the harmonisation of digital medical device evaluation across Europe. By offering a common taxonomy and a structured set of evidence requirements, these tools help align national approaches, clarify expectations for developers and support collaboration between EU Member States. They are not only practical instruments for evaluation but also strategic enablers for the broader integration of digital health into national systems.
As health technologies become more data-driven and AI-enabled, the need for robust, adaptable and interoperable assessment frameworks will only increase. The continued development and adoption of the CEUGrid-DMD and the Evidence Matrix will be key to ensuring that the most effective and trustworthy digital innovations reach healthcare professionals and patients across Europe.
Source: npj digital medicine
Image Credit: iStock
