EU MDR extension and medical device compliance: the implications for product labeling and patient safety


The recent extension to the implementation of the EU MDR (European Medical Device Regulation) still presents challenges for medical device manufacturers. With more than 500,000 types of medical devices on the market, EU MDR has paved the way to supplying a more patient-focused approach to regulations.

Failure to comply with labeling challenges outlined in EUDAMED (European Database on  Medical Devices) will mean that several companies will fail to register or re-register their products. Indeed, this will lead to the loss of the European market or an interruption in the supply chain.

There is currently no doubt that companies are aware that labeling is a mission-critical aspect of the supply chain. However, too few companies have the labeling and packaging artwork solutions in place that will guarantee regulatory compliance, efficiency, validation, brand consistency, responsiveness, customer satisfaction, and revenue.

Learn more about how medical device manufacturers can standardize and automate labeling and packaging across a global landscape to address pressing demands around EU MDR.

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