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The new EU Medical Devices and In Vitro Diagnostical Medical Devices regulations are presenting huge challenges for medical device manufacturers, with thousands of products impacted and requiring label and IFU updates in order to be compliant. Additional content needs to be included on device packaging and labeling, including a Unique Device Identifier (UDI), new symbols and warning statements. Without an end-to-end artwork and labeling management system, manufacturers will find it almost impossible to comply.

How does Kallik help with EU MDR and IVDR?



How Kallik can help


Labels and IFUs are not often held in a central repository, meaning that it can be difficult to locate and identify these for update. Identifying which labels and IFUs require change is a manual process which can take weeks if not months to complete

All labels and IFUs are stored in a central Asset Manager and impacted labels and IFUs are instantly identified using Veraciti™'s ‘Where Used’ functionality


Updating thousands of IFUs and labels is a resource-heavy activity and can take months to complete

Mass changes can be made to thousands of artworks in hours, not months, using Veraciti™’s automated artwork capabilities


Managing the approval process using manual spreadsheet tracking and emails is risky, prone to error and makes proving compliance difficult

Ensure compliance with automated approval routing, task management, e-signatures and detailed audit trails


Label and IFU artworks need to be emailed to the factory or transferred into a separate system used for printing, creating a risk the wrong version is printed

Easily print the finished labels directly from the same system, ensuring only the latest version can be printed


Updated artwork files are emailed or transferred to third party printers using manual processes, risking the wrong version of the label being printed. eIFUs need to be manually uploaded to the relevant platform, risking misalignment between the approved file and the one published online.

Instantly distribute the approved artwork to third party printers from within the system. eIFUs are instantly published following approval, meaning the latest version is always accessible to the patient.

Medical Device Labels Before VS After MDR

Talk to the experts in compliant labeling and artwork

Kallik’s labeling and artwork management software, Veraciti, has been specifically developed for the needs of medical device manufacturers. We have supported many medical device companies with their journey towards EU MDR and IVDR compliant labeling and artwork. Our experienced team can help you, too.

Check out our latest Medical Device resources