The FDA established the Unique Identification System (UDI) to identify medical devices sold in the US from the point of manufacturing and distribution all the way to patient use. The UDI final rule requires device labelers to: Include a UDI on device labels and packages, except where the rule provides for an exception or alternative. […]
Managing the requirements and following the guidelines when it comes to regulatory compliance labeling can be a challenge. Especially for organizations in the chemical, medical, and food & beverage industries. It’s become a higher priority for companies with adherence to strict and evolving policies that have placed additional demands for compliance labeling. Chemicals: Global harmonized […]
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 […]
The European Commission legislation is introducing new compliance requirements on medical devices and creating completely new medical device regulations (MDR). Following in the footsteps of the Food and Drug administration of the US, EU has decided to adopt the Unique Device Identifier (UDI) for all medical devices and In Vitro Diagnostics (IVDR). This will be […]
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 […]
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 […]
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 […]
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 […]
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 […]