Solutions
Life Sciences
Medical device and pharmaceutical manufacturers carry the heaviest labeling burden of any industry: the content is prescribed, the change control is audited, and the same product record has to satisfy four regulators that agree on very little.
What makes it hard.
The label is where recalls start.
Labeling and packaging defects account for a substantial share of device recalls: a wrong translation, an out-of-date instruction for use, incorrect lot or expiry data. These are data and process failures rather than manufacturing faults, which is exactly why controls prevent them.
Four regulators, one device.
FDA, the EU notified body system, ANVISA and NMPA each define their own identifiers, data sets and language requirements. Maintained separately they drift, and the discrepancy surfaces as a rejected submission or an inspection finding.
Validation makes change expensive.
Every system change carries qualification effort, so a labeling platform that makes change cheap by making it uncontrolled is not an option. The control model has to be designed in.
The record has to outlive the product.
For an implantable device, the label that shipped may need to be reproducible decades later. Retention and retrievability are design decisions, not operational hopes.
The rulebook
What you answer to.
The regulations and standards that govern labeling in this industry. Always check the current text before relying on any of them.
- 21 CFR Part 11: electronic records and electronic signatures
- EU MDR 2017/745 and IVDR 2017/746: label content, symbols, EUDAMED
- 21 CFR 830 and FDA GUDID: Unique Device Identification
- ANVISA RDC 591/2021: Brazilian UDI carriers and label content
- NMPA UDI: coding at the smallest sales unit
- ISO 15223-1 and ISO 20417: symbols and information supplied
- EU Regulation 2021/2226: electronic instructions for use
- EU FMD 2011/62/EU and US DSCSA: pharmaceutical serialisation
The outputs
What has to agree.
Produced by separate systems these drift apart. Produced from one record they cannot.
- Printed device or medicine label
- UDI carrier and identifiers on the label and every packaging level
- Electronic instructions for use
- Batch record and audit trail
The capabilities that carry it.
Label Management
Design, approve and print labels from one controlled source, with electronic approval and a complete audit trail on every change.
eLabeling
Electronic instructions for use, published to a regulator-compliant portal and versioned in step with the printed label.
Serialization
Unique serial numbers issued, applied and recorded under the same change control as the rest of the label, at production line speed.
Questions about this industry.
Does this cover both medical devices and pharmaceuticals?
Yes. Device labeling centres on UDI, symbols and instructions for use; pharmaceutical labeling carries heavier market-specific content and serialisation obligations under the EU Falsified Medicines Directive and the US Drug Supply Chain Security Act. Both require validated change control, and both are served by the same control model.
We are a contract manufacturer labeling on behalf of others. Does that change anything?
The regulatory content belongs to the legal manufacturer, but the printing and the records happen at your site, so the audit trail has to be attributable across both organisations. Destination-driven content and per-customer configuration matter more here than in a single-brand operation.
Other industries
Ditch the manual redlining.
Watch automated audit trails build themselves.