In-Sight 3800 Series
General-purpose, AI-powered vision system designed to handle high-speed, high-resolution inspections across a wide range of manufacturing applications.
The importance of UDI compliance
With millions of devices moving through the healthcare supply chain, accurate unique device identification (UDI) marking and verification are critical for traceability and compliance. Every medical device must carry a unique code – on a label or directly on the device – that identifies key product details.
A UDI typically contains a:
- Device Identifier (DI): Identifies the specific version or model of a device
- Production Identifier (PI): Includes lot or batch number, serial number, manufacture date, and expiration date
Additional details may be required depending on regulatory guidelines.
A medical device is considered UDI compliant when its identifier is properly assigned, marked, and verified according to global standards:
- U.S. Food and Drug Administration (FDA): Requires all medical devices to carry a unique identifier with device and production information, ensuring traceability and patient safety
- European Union Medical Device Regulation (EU MDR) and In-Vitro Diagnostic Device Regulation (IVDR): Mandates UDI marking on medical devices and in vitro diagnostics to prevent counterfeit products and maintain compliance across the supply chain.
Proper marking ensures codes are accurate, readable, and traceable throughout the device lifecycle – critical for recalls, identifying expired or faulty products, and preventing counterfeit devices. To keep pace, advanced machine vision, AI-powered OCR, and inline verification tools deliver the speed and accuracy manufacturers need.
High resolution machine vision systems track multiple medical device UDI codes in a single field of view.
The challenges of reading UDIs
Barcodes can be applied using thermal transfer labels or direct part marking. Direct part marks (DPMs) are inherently difficult to read, though: since the code is physically imprinted onto the device, DPM codes often have low contrast.
Other difficulties reading DPMs include:
- Specular glare
- Nonuniform surfaces
- Poor print quality and inconsistent or damaged codes
- Lack of real-time feedback that can lead to rework
Streamlining UDI compliance with AI
Cognex vision systems use powerful image formation and decoding technologies to read DPM and label-based UDIs in challenging environments, even if codes are damaged or obscured. High-dynamic range plus (HDR+) maximizes contrast while accounting for glare and codes on curved surfaces. Embedded pre-trained AI learns by example, enabling Cognex OCR tools to read damaged codes, increasing read rates, and streamlining compliance.
Barcode verification lets you know if your barcodes meet regulatory standards and can pinpoint the cause of any issues, such as figuring out if a barcode or scanner is the cause of a no-read. In-line, offline, and handheld ISO-compliant barcode verifiers analyze 1D/2D barcodes in challenging settings and produce immediate quality reports.
Backed by a network of global experts, Cognex empowers manufacturers to meet UDI requirements with confidence, reduce compliance risks, and protect patient safety throughout the entire device lifecycle.