Proven in real
industrial conditions.

Patient-specific medical devices require testing environments that reflect the anatomy and physiological conditions in which a device will be used. Developing these environments is costly and complex: manufacturers need repeatable models, reliable material and process information, and credible evidence that test conditions are relevant to the intended clinical setting.

ATU develops bespoke anatomical models from clinical data. The models reproduce relevant mechanical properties of target vasculature, support X-ray and ultrasound imaging, and can represent healthy or diseased tissue. Combined with simulation systems for physiological conditions, they provide a repeatable in-house environment for device development and testing, reducing dependence on animal studies and shortening development cycles.

COMPLIANCE4DPP demonstrates how the data and evidence behind these models can become a trusted, interoperable compliance record. Material provenance, additive-manufacturing parameters, model specifications, test conditions and resulting evidence are linked to the relevant requirements through a Digital Product Passport. Machine-readable policies define which evidence is needed and who may access it; verifiable credentials allow trusted parties to attest to data origin, process execution and test results.

Sensitive clinical data remains within the authorised data environment. Using a Compute-to-Data approach, approved analyses can be performed without exposing raw patient data through the DPP. The DPP instead holds controlled references, provenance and verifiable evidence, supporting data minimisation, confidentiality and auditability.

The pilot shows how a DPP can support privacy-preserving compliance evidence for patient-specific medical-device development—not by certifying a device automatically, but by making the underlying evidence more traceable, reusable and assessable.

Carbide tools are used throughout manufacturing because tungsten, cobalt and other metals give them high wear and heat resistance. Since much of Europe’s supply of these materials is imported, extending tool use and recovering materials at end of life are important for cost resilience, supply security and resource efficiency.

Today, information needed to make circular decisions is fragmented across tool producers, users, reconditioning services and recyclers. A recycler may not know a tool’s composition or condition; a reconditioner may lack reliable use and service history; and manufacturers may be unable to substantiate circularity or recovery claims across a distributed value chain.

COMPLIANCE4DPP uses a Digital Product Passport to create a trusted, product-level evidence chain. Each manufactured tool is linked to structured lifecycle information, including material and production data, use and condition information, reconditioning events, custody history, and end-of-life treatment. Partners retain control of commercially sensitive source data while sharing authorised, interoperable claims and verifiable credentials through a federated data ecosystem.

Machine-readable policies define the evidence required for decisions such as reconditioning, recycling and recovery reporting. The resulting DPP record allows participating organisations to assess whether a tool is suitable for a next use cycle, identify an appropriate recovery route, and substantiate material-recovery information without relying on disconnected documents or unverified declarations.

The pilot demonstrates how COMPLIANCE4DPP turns circularity requirements and partner-specific rules into operational data processes. It contributes to the objectives of the EU Circular Economy Action Plan and Critical Raw Materials Act by improving trusted access to the information needed to retain carbide materials in the European economy.