Every medical device pack has to carry the right UDI twice, once as a GS1 DataMatrix and once as plain text, and both have to agree with each other, with the work order and with the device record in GUDID. A carton from the last job, an expiry keyed by hand or a code that has faded to a poor grade can turn into a mislabeled lot and a recall. AI vision reads, checks and grades every pack at line speed. See it on real device labels in a short UDI vision demo.
Read, Check and Grade Every UDI Before the Pack Ships
iFactory Vision OCR Inspection reads the GS1 DataMatrix and the human-readable UDI on every pack, compares the DI and PI against GUDID or your master data, and grades print quality. Mislabeled packs are blocked before they reach the case.
What the FDA Rules Ask of Every Device Label
FDA's UDI rule sits mainly in 21 CFR Part 801 Subpart B and Part 830. The UDI must be issued under a system run by an FDA-accredited issuing agency, which today means GS1, HIBCC or ICCBBA. This page uses GS1 examples throughout. Check how these rules apply to your device range in a UDI labeling review.
One Device Identifier, Several Production Identifiers
A UDI has two parts. The device identifier (DI) names the model and package level and never changes for that version. The production identifier (PI) carries what changes from lot to lot or unit to unit. In GS1 terms, each part is marked with an Application Identifier, the number in brackets that also appears in the human-readable text. Map your own label fields with our support team.
Reading the Code Is Not the Same as Grading It
Two different checks often get the same name. Reading, sometimes called validation, decodes the symbol and checks that the data is right. Verification grades how well the symbol is printed against ISO/IEC 15415. The GS1 DataMatrix Guideline warns not to confuse the two, and notes that some symbols that fail verification can still be read by some scanners. A code that reads today on your line may not read at a hospital. Compare both checks on your packs in a sample pack test.
- Does the symbol decode at all?
- Is the GS1 syntax and check digit valid?
- Do DI and PI match the work order?
- Does the plain text say the same thing?
- Symbol contrast and modulation
- Fixed pattern damage
- Axial and grid nonuniformity
- Unused error correction
What a 1.5/08/660 Grade Actually Means
ISO/IEC 15415 grades a 2D symbol from 4 (best) to 0, or A to F. Each image gets a scan grade equal to its lowest parameter, and the overall grade is the average across the images tested. GS1 writes the requirement as grade, aperture and light: for regulated healthcare items not scanned at retail, its minimum is 1.5/08/660, meaning grade 1.5 or better, an 8 mil aperture and 660 nm red light. Set the right grade limits for your printers with our print quality team.
A camera on the line can grade every code and show the trend as a printhead wears. A formal ISO grade comes from a verifier built and calibrated to ISO/IEC 15426-2. Most plants use both: in-line grading to catch drift on every pack, and a calibrated verifier to confirm the grade on samples.
Find Out Why a Pack Was Blocked in Seconds
Every block comes with the image, the decoded data, the text read and the grade. QA can ask iFactory what happened in plain language and get a clear answer, instead of pulling cartons apart at the end of the shift.
Six Checks Behind Every Pass
GUDID holds the device identifier and its attributes, not lot or serial values. It also holds flags for which production identifiers your UDI carries. That makes it a good reference: the DI on the pack must belong to the product being run, and the PI fields printed must be the ones the record says to expect. iFactory works from a master data copy you approve, so the line never depends on a live connection. See the full check sequence in a line walkthrough.
Running One Line for Both the US and the EU
Under the EU MDR, Article 27 and Annex VI set out the UDI system, and EUDAMED holds the device data. The label carries the UDI carrier, in AIDC and human-readable form, built from the UDI-DI and UDI-PI. The Basic UDI-DI groups models for EUDAMED, certificates and the declaration of conformity, and does not appear on the label. A pack built for both markets has to satisfy both sets of rules. Compare your label set against both in a call with our regulatory support team.
What 820.45 Expects Under the QMSR
The QMSR took effect on 2 February 2026 and amended Part 820 to incorporate ISO 13485:2016. Labeling control stayed in the rule: section 820.45 adds to ISO 13485 clause 7.5.1 and asks for labeling and packaging to be examined for accuracy before release or storage, for operations that prevent mixups, and for results documented under clause 4.2.5. Walk through your labeling procedure in a QMSR labeling session.
A Run Checklist for UDI Labeling Lines
Vision does the per-pack work, but the run still starts and ends with people. Use this checklist at each changeover and through the run. Tick items as you go, and adapt it to your own procedure. Ask our support team for an editable copy.
Three Typical Catches on a Device Packaging Line
These illustrations show how the checks usually respond. They are not case studies, and the right response always follows your own procedures. Walk through your own label set in a scenario review.
Cameras, OCR Models and Edge Server in One Package
iFactory delivers UDI label inspection as a turnkey bundle. Cameras and lighting are fitted at pouch, carton and case stations, and a pre-configured NVIDIA AI server ships racked and ready with the reading, OCR and grading models loaded, so every pack is checked beside the line. You rack it, plug in power and Ethernet, and the AI is live. To scope it for your packaging lines, ask our support team for a turnkey quote.
- Pre-configured NVIDIA AI edge server, racked and ready
- Cameras and lighting for pouch, carton and case labels
- DataMatrix reading, OCR and print grading models
- Master data link to your GUDID records and ERP
- PLC link for reject gates and line stops
- Per-pack results attached to the lot record
- 24×7 remote monitoring of models and hardware
Label sets, fields and grade limits agreed, cameras and server installed, master data linked.
OCR trained on your fonts and substrates, then run silently beside current checks.
Challenge packs run for qualification, reject gates switched on, operators trained.
Vision OCR Built for Device Pack-Out Inspection
iFactory is designed for regulated packaging lines, where every block must be explained and every pack traced to its lot. We can plan a pilot on one line in a short scoping call.
What Device Quality and Packaging Teams Ask About UDI Checks
Stop Mislabeled Device Packs at the Line
Read both forms of the UDI, check them against your device records, grade every code and block what doesn't match. Delivered turnkey and live in 6 to 12 weeks.
