The requirements laid out by the MDR regulation is likely to result in labeling congestion. Failure to produce accurate, MDR-compliant labeling may result in organizations unable to distribute their products in Europe, causing products to be unnecessarily stockpiled or even resulting in costly, product recalls. Organizations may require a major redesign of label layouts and possibly accelerate the move from linear to 2D bar codes to capture more data in a machine-readable format. Amidst changes in the existing regulatory framework, labeling directly integrated with centralized data repositories is a valuable compliance tool. To ensure compliance with the regulation and manage medical device labeling, it is critical to take small steps with the phased approach supported by the right technology/tool and start applying to different labeling processes.
Celegence can provide labeling and artwork solutions with complete label integrity to meet the strictest compliance requirements for the upcoming EU MDR. Celegence team can help you evaluate if your organization is ready for EU MDR labeling requirements.