Custom Labels
Pressure-sensitive labels in any size, shape, and material for medical device packaging — including UDI-compliant labels, barcode labels, lot/date coding, and multilingual versions for global markets.
Labels are the primary communication interface between your medical device and the healthcare professional using it. At PPR, we supply custom pressure-sensitive labels that meet FDA, EU MDR, and ISO 15223-1 requirements — from simple identification labels to complex UDI-compliant labels with variable data, barcodes, and multiple language versions.
UDI-Compliant Labels
Labels designed to carry the Unique Device Identifier (UDI) in human-readable and machine-readable (barcode/QR) formats per FDA 21 CFR Part 830 and EU MDR Annex VI requirements.
Barcode Labels
GS1-128, Code 128, Code 39, DataMatrix, QR, and ITF-14 barcodes printed at high resolution for reliable scan performance. Barcode verification testing available.
Variable Data & Lot/Date Coding
Thermal transfer overprinting (TTO) for variable lot number, expiration date, and serial number. Inkjet and laser coding also supported.
Specialty Materials
Label materials including polyester (durable, waterproof), polypropylene (flexible), Tyvek® (tear-resistant, sterilization compatible), and cryogenic labels for frozen storage.
RFID Labels
Radio-frequency identification (RFID) labels for medical device tracking, inventory management, and supply chain visibility. UHF and HF RFID inlays embedded in pressure-sensitive label stock, compatible with GS1 EPC standards and hospital asset tracking systems.
GHS & Hazard Labels
GHS-compliant hazard communication labels for medical devices containing hazardous chemicals. Designed to OSHA HazCom 2012 and CLP regulation requirements.
Standard Process:
Discovery & Requirements
Device specs, sterilization method, use environment, and regulatory pathwayreviewed with your team.
Design + Development
Artwork and specification sheets provided, or new packaging concepts engineeredby our team.
Prototypes + Proposal
Prototypes available for testing and validation. Once approved, pricing and termsare determined.
Validation
IQ/OQ/PQ executed. Accelerated aging and distribution simulation testingcompleted per ISO 11607.
Final Approval + Production
Proofs made to match drawings and specifications. Validated design transferred tofull production.
Materials & Options
- ISO 15223-1
Medical device symbols for labels - FDA 21 CFR Part 830
UDI requirements - EU MDR 2018/745 Annex VI
EU UDI - GS1 Standards
Barcode data structure and formatting - Materials
Polyester, polypropylene, Tyvek®, paper, cryogenic - Adhesives
Permanent, removable, freezer-grade, medical-grade
Device Categories We Support
Custom Labels
We manage labels as part of your complete packaging system — coordinated with your cartons, IFUs, and barcoding requirements so nothing gets misaligned between vendors.
Labels touch every part of your packaging system — cartons, pouches, shippers, and the device itself. We coordinate all of it through a single source, matching materials, adhesives, and print methods to each surface so nothing peels, smears, or fails in the field.
