Evidence Matrix for Digital Medical Devices
The Evidence Matrix for Digital Medical Devices is a structured framework developed to support consistent evaluation of digital medical devices across the European Union. It works alongside a classification grid to help assessors determine what evidence is needed based on the characteristics of the device.
At a glance
Use when
Evaluating digital medical devices within or across EU healthcare systems, particularly in preparation for joint clinical assessments under the EU HTA Regulation.
Avoid when
Assessing non-digital or traditional medical devices; when local regulatory or HTA requirements significantly diverge from EU-level frameworks.
Inputs
Classification of the digital medical device according to the CEUGrid-DMD taxonomy (e.g., level of autonomy, data processing type, clinical function, risk level).
Outputs
Structured overview of required evidence across HTA domains tailored to the device classification.
How it works
The Evidence Matrix is part of the CEUGrid-DMD, developed by the HTx project's Taskforce for Harmonised Evaluation of DMDs. It maps required evidence types to four taxonomy categories of digital medical devices (DMDs), informed by a survey of HTA practices across 18 EU countries and consensus-building activities. The matrix supports HTA bodies in generating comprehensive, comparable assessments aligned with emerging EU regulations.
- Project
- HTx
- Funding
- Horizon 2020
- Project status
- Completed 2024
- HTA domains
- Clinical Effectiveness, Safety, Organisational aspects
- Assumptions
- Digital medical devices can be meaningfully classified into a common taxonomy; evidence requirements can be systematically linked to device characteristics; harmonization improves assessment efficiency and comparability across EU HTA bodies.
- Strengths
- Promotes cross-border harmonization of DMD assessments; based on input from multiple EU HTA bodies; aligns with upcoming EU HTA regulations; supports systematic and transparent evidence planning.
- Limitations
- Limited by varying national implementation capacities; some HTA bodies lacked active DMD evaluation frameworks at time of development; may require updates as technology and regulations evolve.
- Also known as
- Evidence Matrix, CEUGrid-DMD Evidence Matrix, HTx Evidence Matrix
Questions this answers
- › What types of evidence are required for evaluating a digital medical device?
- › How does the level of evidence needed vary with the risk and function of the device?
- › Which HTA domains should be addressed for a given DMD classification?
- › How can evidence requirements be harmonized across EU member states?
- › What gaps exist in current HTA practices for digital medical devices?
- › How can classification of DMDs inform targeted evidence generation?
References & sources
Related methods
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.