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The Impact of COVID-19 on Medical Device Labeling

FLEXcon Agency Listings & Regulatory Specialist Jim Potter headshot

Winning a war often means throwing everything you’ve got at it. For manufacturers during the COVID-19 pandemic, this means ramping up production of medical devices such as ventilators, and for some manufacturers, completely shifting production to a new industry, as automotive manufacturers are now doing. It is similar to the shift from producing cars to producing airplanes and tanks during WWII.

Doc with patient on ventilator

High demand for medical devices means high demand for medical device labels. For manufacturers that already play in this space, this can mean opening up their specs to allow for the use of alternative materials in order to get what they need, while for those outside the medical industry, UL approval must be obtained for every product component, including the labels.

In all cases, for medical device labels to be compliant, they must meet certain durability requirements as well as contain certain information, both as required by UL/IEC 60601-1, 3rd edition, as amended. The challenge for converters is getting those materials added to their UL listings, often in short order, to meet the demands of their customers.

UL Requirements

The good news is that UL is working to streamline adoptions of certified label materials to quickly enable converters to utilize them. A paperwork transfer is still all that’s required, and it can be expedited for an additional fee.

An important distinction to note is that the UL/IEC combined recognition of labeling materials carries testing beyond that required for UL-recognized label stocks generally, so to be in compliance, label converters must use label stocks that carry this recognition. For those that don’t typically play in this space, it’s necessary to understand that the UL print media on-hand may not be recognized under this standard, and that adoption of new materials may be required.

Under the FDA guidelines enacted in 2013, medical device labels must also contain specific information:

  • name and address of manufacturer, packer or distributor
  • unique device identifier (UDI) code
  • expiration date
  • control number if the device is subject to 21 CFR Part 820.65
  • storage and handling instructions
  • indications of use

Manufacturers that are new to the medical space, as well as their label converters, need to understand these regulations and ensure that (a) labels contain the requisite information, and (b) the label stocks used meet the combined UL/IEC standard.

Are you facing a challenge regarding UL adoption or acquiring appropriate materials for medical device labeling? FLEXcon can help. Contact us today.

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