What is IVDR and how does it affect labeling and artwork management?


Navigate the complexities of the In Vitro Diagnostic Regulation (IVDR) with Kallik’s advanced labeling and artwork management solutions. Designed specifically for in vitro diagnostic manufacturers, our intuitive software streamlines the creation of compliant labels, ensuring accuracy and adherence to stringent regulatory requirements.

With powerful automation, seamless approval workflows, and comprehensive version control, Kallik’s software simplifies the labeling process, helping you meet the high standards of the IVDR while reducing errors and accelerating your time to market. Enhance product safety, maintain traceability, and confidently scale your in vitro diagnostics business with Kallik’s trusted solutions.
 


What is IVDR?


The In Vitro Diagnostic Regulation (IVDR) is a set of European Union regulations that governs the production and commercialization of in vitro diagnostic medical devices. It aims to improve the safety, transparency, and performance of these devices by setting more rigorous requirements for their clinical evaluation, risk management, and post-market surveillance.
 

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How medical device manufacturers are affected by IVDR: Companies that produce in vitro diagnostic devices, such as blood glucose monitors, pregnancy tests, and molecular diagnostics, must comply with the IVDR. Under IVDR, products must adhere to stringent standards to ensure product safety and effectiveness. This includes risk classification, where IVDs are categorized from Class A to Class D, with higher-risk devices facing more rigorous scrutiny.

Impact on Labeling and Artwork Management


IVDR introduces stricter labeling requirements for in vitro diagnostic devices, including the need for detailed product information, usage instructions, and safety warnings in all relevant languages across the EU. Non-compliance with these requirements can lead to market access issues, product recalls, or legal penalties. Labeling teams must ensure that all packaging and artwork materials reflect the new standards, with frequent updates to meet evolving regulatory demands.
 

 

How Veraciti Can Help with IVDR Compliance


Veraciti is designed to handle the complexities of IVDR compliance by offering a robust solution for managing multilingual labeling requirements and ensuring accuracy across all regions. Our software enables easy updates to product information and artwork, reducing the time and effort needed to implement changes. With a thorough approval process and comprehensive reporting, Veraciti helps businesses avoid costly errors, ensuring their labels meet IVDR standards and are ready for market release.

 

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Kallik labeling and artwork management software