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Benefits of a Standardized Labeling Solution

With manufacturing plant locations and distribution facilities operating globally, companies are seeing the benefits of developing a standardized global labeling approach. Pragmatyxs has been engaged in developing solutions for global label operations for many years. We have consulted with many organizations that have multiple plant locations in migrating from their own custom legacy labeling solutions […]


MDR/IVDR

Much like the experience we have all recently gained in the United States during the deployment of UDI for Class 3 and now Class 2 devices and soon Class 1. The goals of the European Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR) are to provide for the safety and well-being of the consumers […]


COMPLIANCE LABELING- BENEFITS OF AN EXPERIENCED INTEGRATOR.

When it comes to making labeling work across global supply chains, many organizations have tried to meet their evolving needs through a variety of homegrown custom solutions. Such solutions may provide steps in the right direction, but they don’t get the job done adequately. These solutions can work to solve immediate challenges but are not […]


Food & Beverage Compliance requirements

Here are some examples of the requirements for labeling in Food & Beverage Examples: The FDA’s Food Safety and Modernization Act (FSMA), aimed at preventing food contamination across every step of the supply chain, including use of imports and exports across international boundaries. FSMA also gives the FDA authority to order a mandatory recall of […]


UDI Labeling in 2018

With 2017 coming to an end, it is a good time to preview what is upcoming in 2018 for medical device labeling in the US. The Unique Device Identification Rule has been a popular topic over the past two years and it has achieved many milestones, requiring medical device manufacturers to follow labeling on Class […]


Why UDI & MDR?

In the barcode industry, there is considerable dialogue about (UDI) Unique Device Identification and (MDR) –Medical Device Regulation. We read and hear all about the initiatives and the deadlines, but why are these compliance requirements so important….   These compliance regulations provide for more accurate reporting, content review and the ability to report on device […]


FDA UDI Class I

Several dates for UDI compliance have been postponed: •         Class I and unclassified devices – 24th of September, 2020 •         Direct Marking of Class I and unclassified devices – 24th of September 2022 Low-risk devices are required to follow the UDI ruling two years later than it was originally planned (24th of September 2018). Class […]


UDI Exceptions on Single Use Devices

Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]


FDA Extends Mandates for Certain Class II Devices

The US Food and Drug Administration (FDA) is extending the deadline to comply with unique device identifier (UDI) requirements for certain Class II devices. The first mandate posted was that all Class II devices must be in compliance by September of 2016. Now, FDA says it is extending the compliance date for certain Class II […]


European Commissions (EU) latest revision for UDI

The European Commission (EU) announced its latest revisions to the proposed rule changes for unique device identification (UDI) requirements. The agreement has been in the development stage for the past year and the EU has now developed tighter rules for medical manufactures. These rules center on areas such as trace-ability and are designed to ensure […]