Medical Device Manufacturers Must Create Better UDI Labels

Medical device manufacturers cannot afford to introduce products to the market without thinking carefully about labeling. Given the sensitive nature of medical devices – many of which are used for life saving or life sustaining treatments – it’s important to create labels that contain clear instructions for safe use. This has proven to be even more true during the steady implementation of the FDA’s Unique Device Identification rules.

A label isn’t functional if it is not legible.

By September of this year, the federal agency will mandate that all Class 3 medical devices to bear permanent markings. These include implantable pacemakers and breast implants.

At the same time, all Class 2 medical devices will be required to have UDIs inscribed on their labels and packages. Most devices fall under this category, such as pregnancy tests.

As they work to comply with upcoming rules, medical device manufacturers have an opportunity to create labels that both providers and patients will find useful. As noted by a recent article on Medical Device Online, a label isn’t functional if it is not legible.

Font should be large enough so those who may have difficulty reading standard text sizes can understand what they are looking at. There should be enough contrast between the test and the background so the label is readable, even in low light. And color should be used where possible to draw attention to the important information on the label.

Medical device manufacturers need the ability to print clear, effective labels on a wide variety of materials. Durafast offers printing solutions that help you produce exactly what you are looking for in a cost-effective manner. Contact us today!