Device identifiers, manufacturer data, materials, evidence and lifecycle traceability.
A medical-device readiness record should map UDI and device identity to manufacturer, materials, technical documentation, safety evidence and lifecycle traceability without presenting the DPP as a substitute for MDR duties.
Regulatory content reviewed 8 October 2026
The rules below do different jobs. Some are enforceable sector requirements, some establish the DPP architecture, and some announce future product measures. Each card explains the distinction.
Organize the record in stable blocks so identity, technical facts, evidence and access rules can change without losing provenance.
Defines exactly which model, batch or item the record describes.
Technical documentation
Connects components, materials, suppliers and facilities.
Clinical and conformity evidence
Holds measured, calculated and declared product attributes with their basis.
Post-market surveillance records
Maintains repair, use, custody and end-of-life information over time.
Supplier and quality-management records
Technical documentation · Clinical and conformity evidence · Post-market surveillance records · Supplier and quality-management records
A battery passport published on DPP Shield: identifiers, materials, substances of concern, carbon footprint, repair information, six evidence documents and a verifiable credential you can check.
Demonstration data for illustration, not a real product.Identify the exact product, economic-operator role, market and applicable legislation.
Map authoritative source records to stable product, operator and facility identifiers.
Review completeness, consistency, access rights and the evidence behind each claim.
Approve a versioned public view while protecting restricted and personal data.
No. Existing medical-device identifiers and regulatory systems remain authoritative; integrations should map them rather than create conflicting identities.
Organize at least four governed blocks: UDI, device and manufacturer identity; Materials and critical components; Intended purpose, safety and performance; Distribution, servicing and lifecycle traceability. Every value should retain its source, effective date, product level and review status.
The evidence file should cover Technical documentation; Clinical and conformity evidence; Post-market surveillance records; Supplier and quality-management records. A public view can cite approved evidence without exposing restricted files or confidential data.
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