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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 […]


How do I manage all the projects that I have and still get compliant on UDI?

UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you  have additional requirements to maintain these […]


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 […]


510(K) Medical Device Exemptions

FDA announced this week a list of more than 1,000 medical devices that will now be exempt from 510(k) notification requirements — a move that aims to help speed up the process of bringing new medical devices to market. The decision was made this week in accordance with a process laid out by the 21st […]


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 […]


Improving your labeling process to be more efficient.

Companies worldwide are challenged with developing and maintaining efficient disciplined product labeling. They are tasked with a wide range of internal requirements, Marketing and Product Branding and external regulatory requirements, such as GHS or UDI compliance requirements. As example, the chemical industry and their respective supply chains are continuously evolving and have as complex a […]


Class III Medical Devices; News and Information

The first compliance date for Unique device identification, UDI, class III was September 2014. Class III medical devices are defined as devices that support or sustain human lives, Class III Medical Devices include implanted pacemakers, heart valves and implanted cerebral simulators. At that time the FDA mandated that labels and packages of class III medical […]


Benefits of a UDI System

When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]