Master data and templates
Control product identifiers, issuing-agency syntax, label layouts, human-readable content and approved versions.
UDI, Data Matrix and controlled records
Medical-device UDI and barcode traceability systems
Create, apply, verify and retain medical-device identities across labels, packaging and direct part marking, with production controls built around the applicable market requirement.
Direct answer
UDI projects connect regulated identity with a controlled manufacturing process.
A Unique Device Identifier normally contains a device identifier and production information such as lot, serial, manufacture or expiry data, represented in human-readable and machine-readable form according to the applicable rules and issuing system.
Oxford Traceability supports the production implementation: label printing, direct marking, code verification, serialisation, database or line integration and evidence that the intended identity was applied to the correct device or packaging level. Regulatory interpretation remains the manufacturer's responsibility and should be confirmed for each market.
- Identity
- UDI-DI and applicable UDI-PI data
- Carriers
- GS1 DataMatrix, labels and DPM
- Controls
- Template, data, read-back and reject
- Evidence
- Serial, batch, grade and production record
Controlled identity chain
Protect every hand-off from source data to released product.
The reliable system controls not only print quality but also template selection, variable data, product association and retained evidence.
Printing or direct marking
Select label, TIJ, laser or other marking technology around material, available space, durability and process validation.
Verification and inspection
Grade code quality where required, validate encoded content and confirm the correct identity at the production step.
Serialisation and records
Allocate or receive serials, prevent reuse, associate production events and retain searchable evidence for the required period.
Project sequence
Turn the UDI requirement into testable production controls.
The scope should distinguish regulatory data, customer specifications, code-quality criteria and manufacturing acceptance tests.
Confirm market requirements
Identify the device, packaging levels, markets, issuing system, required dates and governing regulatory or customer documents.
Define data and carrier
Map identifier sources, variable UDI-PI fields, symbol, size, placement, human-readable content and permanence.
Prove print or mark quality
Test representative products through processing, handling or reprocessing conditions and confirm the verification method.
Validate the operating sequence
Test template control, serial handling, line clearance, read-back, reject, rework, audit trail and recovery states.
Authoritative references
Useful standards and regulatory sources.
Requirements vary by product, market and customer specification. Confirm the current rules that apply to your project.
Frequently asked questions
Medical-device UDI implementation: practical questions
Practical answers to common buying and implementation questions.
What is the difference between UDI-DI and UDI-PI?+
The UDI-DI identifies the device model or version, while UDI-PI represents production information that may include lot, serial, manufacture date or expiry date as required for the device and market.
Can a Data Matrix code be applied directly to a reusable device?+
Potentially, using a suitable direct-part-marking method and placement. Material response, code size, surface finish, reprocessing exposure, readability and the applicable regulatory exceptions must be assessed.
Does decoding the UDI prove code quality?+
No. Decoding confirms that a reader extracted data. Where a quality grade is required, a calibrated verifier and the applicable print or direct-mark verification method should be used.
Can production records link a UDI serial to inspection results?+
Yes. A serialisation and genealogy layer can associate the issued identity with manufacturing order, components, process results, inspection, rework, release and packaging events.
Related routes
Continue from equipment to outcome.
Discuss your application
Planning UDI marking or verification on a production line?
Share the device, target market, packaging levels, proposed symbology, code size and current data source. We will help define the production technology and trial plan.