UDI is an acronym for Unique Device Identification. In 2013, the U.S. FDA UDI Final Rule required device labelers (typically,
the manufacturers) to:

1. Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency’s UDI system, on device labels, device packages, and in some instances, directly on the device.
2. Submit device information to the Global Unique Device Identification Database (GUDID).

The UDI is a unique numeric or alphanumeric code that contains two parts, the device identifier (DI) and the production identifier (PI) portions.

For more information visit: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics

When fully implemented, the UDI System will offer a range of benefits to the healthcare industry, healthcare consumers, healthcare providers, the FDA, and manufacturers.

The benefits are:
1. Enhancing post-market analysis of devices on the market by providing a clear standard for documenting medical devices in
the electronic health record, clinical information systems, claim data sources, and registries.

2. Accurate reporting, reviewing and analyzing of medical device adverse event reports so devices with issues can be identified and corrected quicker.

3. Enables healthcare professionals and others the ability to accurately identify a device and obtain important information about
the device.

4. Effective and efficient standard for the management of medical device recalls.

5.Helping to address counterfeit medical devices by providing the foundation for a global, secure distribution chain.

For additional information visit:
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/benefits-udi-system

When fully implemented, the UDI System will offer a range of benefits to the healthcare industry, healthcare consumers, healthcare providers, the FDA, and manufacturers.

The benefits are:
1. Enhancing post-market analysis of devices on the market by providing a clear standard for documenting medical devices in
the electronic health record, clinical information systems, claim data sources, and registries.

2. Accurate reporting, reviewing and analyzing of medical device adverse event reports so devices with issues can be identified and corrected quicker.

3. Enables healthcare professionals and others the ability to accurately identify a device and obtain important information about
the device.

4. Effective and efficient standard for the management of medical device recalls.

5.Helping to address counterfeit medical devices by providing the foundation for a global, secure distribution chain.

For additional information visit:
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/benefits-udi-system

The Unique Device Identification System final rule (UDI Rule) requires device labelers (typically, the manufacturer) to:

1. Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative.
– If a device is intended for more than one use and intended to be reprocessed before each use, the device labeler must also mark the UDI directly on the device.

2. Submit device information to the Global Unique Device Identification Database (GUDID).

The device labeler must provide the UDI in two forms on labels and packages:
– Easily readable plain-text
– Machine-readable form that uses automatic identification and data capture (AIDC) technology.
For additional information visit: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics

A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following:

Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
– Lot or batch number within which a device was manufactured;
– Serial number of a specific device;
– Expiration date of a specific device;
– Date a specific device was manufactured;
– Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

For additional information visit: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics

Yes, an FDA-accredited issuing agency is an organization accredited by the FDA to operate a system for assigning unique device identifiers (UDIs) according to the Unique Device Identification System final rule. The FDA has accredited the following issuing agencies: GS1 (Global Standard One); HIBCC (Health Industry Business Communications Council); and ICCBBA (International Council for Commonality in Blood Banking Automation).

The EU MDR is an acronym for the European Union Medical Device Regulation (EU MDR). The EU MDR 2017/745 updated the Medical Device Directive (MDD) 93/42/EEC and the Directive on Active Implantable Medical Devices 90/385/EEC. The EU MDR was written into regulation on May 25, 2017 by the European Commission to ensure a high standard of quality and safety for medical devices being produced in or distributed into Europe. Similar the U.S. FDA UDI Rule, the EU MDR is a robust, transparent, and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. It will assist with identifying medical device products and improve device traceability through the supply chain from the manufacturer to the final user of the device. Standard data, technological advances, and the establishment of an EU database (EUDAMED will provide device transparency for pre-market and post-market surveillance.

For additional information visit: https://ec.europa.eu/growth/sectors/medical-devices_en

The EU MDR contains some of the same requirements that were in the MDD, they have just updated and several new requirements have been added. The new requirements that weren’t addressed in the MDD, but are in the MDR address: post-market surveillance which will require manufacturer’s to produce post-market safety reports (PMS or PSUR); UDI labeling and direct marking based on the device’s class; device data submission into EUDAMED; requirements for importers and distributors; organizations must have one dedicated Quality or Regulatory Compliance or Safety Manager; and there are regulatory requirements for products that do not have a medical purpose (e.g., contact lenses).

For additional information visit: https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05

On April 23, 2020, the European Commission adopted a one-year postponement of the EU MDR 2017/745 regulation due to the COVID-19 pandemic. This means the MDR requirements will be postponed until May 2021. The one-year postponement will not have an impact on the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.

For additional information visit: https://ec.europa.eu/commission/presscorner/detail/en/IP_20_718

ISO 15415, ISO 15416, and ISO 29158, ANSI standards and AIM 2D DPM codes.

Yes! The Tractus platform is designed to work with all major EHR systems through the use of our advanced machine learning and interoperability system.

Yes! We match the non-UDI part or manufacturer reference number with the DI of a UDI, ensuring compliance and accurate inventory utilization data.

Absolutely, the Tractus software system is designed to intelligently feed inventory use and utilization information directly into your inventory system, we even have a free and open API to the system, giving you access to customize reports and parameters as you see fit.

You have the flexibility and choice to either use our comprehensive cloud services or run a local instance of the Tractus server software
at your facility!

Yes! The Tractus platform is designed to work with all scanning systems, new or old. Our software is setup for maximum compatibility and will work with your existing hardware.

Both, the Tractus™ scanner can be used as both a validator which is a process to ensure the information contained in a products barcode has been properly applied to the barcode for the product. Or as a validator which measures and grades the quality of the barcode according to industry standards, such as ISO/ANSI, for a product.

Validation of a medical device’s barcode provides a manufacturing organization with the assurance that the barcode actually scans and that the format of the data is correct for the application in question.

The Verification process for a barcode inspects a number of parameters and assigns each a grade according to a global standard.
It also requires calibration and accurate positioning of lighting elements for consistency. Some of the parameters the Verification
process grades are:
– Minimum Reflectance
– Reflectance Margin
– Symbol Contrast
– Minimum Edge Contrast
– Modulation
– Defects
– Decodability
– Decode

The standard recommends that 10 scans are completed for each parameter (across different parts of the barcode symbol)
and the score for those parameter is the average of the 10.

Neither, a barcode reader is designed specifically to read barcodes. A barcode validator reads the data contained within the barcode to ensure it is formatted correctly so that a computer system receiving the data contained within the barcode can interpret it. A barcode verifier confirms a barcodes’ data has been formatted correctly and can be read by all scanners. If the barcode can not be read it pinpoints the reasons why the barcode will not scan. A barcode verifier prints out a report for the barcode with grades of the barcode to certify it has met industry standards.

While barcode readers are designed to read codes, a barcode verifier ensures that codes are marked correctly and meets industry quality standards, rather than the manufacturer’s quality threshold. Compared to barcode readers, barcode verifiers are a superior measure of symbol readability because they normalize the range of performance among the various types of readers: cameras; lasers; handheld; and fixed-mounted.

Yes, when verifying a barcode the resolution of the verification scanner, as well as the lighting in the area, can have an effect on the results obtained. This is why the StarTrack Scanner uses GS1 recommended aperture settings and blue light, in addition to the standard red light, to illuminate the symbol for reading.

Some barcode validators may, depending on their software, provide printable quality metrics that are useful for process control and improvement. These metrics help manufacturers to print barcodes that meet their unique print quality needs and anticipate whether a generic reader will be able to successfully read their codes. The types of barcode readers a barcode encounters along the supply chain vary widely. In fact, many barcode readers have decoding algorithms designed specifically to read deformed, challenging, and hard-to-read codes. Neither quality control testing nor a scanner’s process control metrics can reliably gauge how two different barcode readers will handle the same code—only a barcode verification can.