Common European Classification Grid for DMDs (CEUGrid-DMD)
The CEUGrid-DMD is a classification system designed to standardize how digital medical devices (DMDs) are assessed across Europe. It helps ensure consistent evaluation by organizing DMDs into clear categories and linking them to the types of evidence needed for health technology assessment.
At a glance
Use when
Classifying digital medical devices for health technology assessment in the European Union; designing evidence generation strategies for DMDs; supporting joint clinical assessments under the EU HTA Regulation.
Avoid when
Assessing non-digital or traditional medical devices; use in non-EU contexts without adaptation; when detailed technical specifications of a DMD are unavailable.
Inputs
Characteristics of a digital medical device across four taxonomy dimensions (e.g., technological, clinical, organizational, and patient-related aspects).
Outputs
A standardized classification of the digital medical device that informs the required evidence profile and assessment pathway within HTA processes.
How it works
The Common European Classification Grid for DMDs (CEUGrid-DMD) is a structured taxonomy developed within the HTx project to support harmonized Health Technology Assessment (HTA) of digital medical devices in the EU. It comprises four main taxonomy categories derived from mapping existing frameworks, surveying HTA practices across 18 EU countries, and expert consensus. The grid is paired with an Evidence Matrix that aligns classification dimensions with required evidence domains. It aims to standardize scientific assessments under the EU HTA Regulation, particularly for cross-border collaboration and joint clinical assessments.
- Project
- HTx
- Funding
- Horizon 2020
- Project status
- Completed 2024
- HTA domains
- Clinical Effectiveness, Organisational aspects, Patient and Social Aspects
- Assumptions
- Digital medical devices require tailored HTA approaches based on their functional and clinical context; harmonization across EU countries is feasible through a shared classification system.
- Strengths
- Supports cross-national consistency in HTA; developed through multi-country stakeholder input; aligns with EU regulatory developments; integrates with an evidence matrix to guide assessment.
- Limitations
- Limited by varying levels of DMD evaluation maturity across EU countries; some HTA bodies lacked experience with DMDs, affecting survey completeness; early version may require refinement as DMD ecosystems evolve.
- Also known as
- CEUGrid-DMD, Common European Classification Grid for Digital Medical Devices
Questions this answers
- › How can digital medical devices be systematically classified for HTA purposes in the EU?
- › What are the key dimensions that differentiate digital medical devices in terms of assessment needs?
- › Which evidence domains are relevant for each type of digital medical device?
- › How do current HTA practices across EU countries handle digital medical devices?
- › What framework can support harmonized evaluation of DMDs under the new EU HTA Regulation?
- › What taxonomy can enable interoperability between regulatory classification and HTA assessment?
References & sources
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