An Overview of Medical Device Labeling

Before we begin our discussion on labeling, let's first define what we mean by labeling because the term is deceptive. The "labeling" of a medical device includes the label that may go on the product itself, PLUS its packaging, the Instructions for Use (IFU), and marketing materials. Aside from translations, there are a few issues which garner a fair amount of attention with regard to labeling. The first is the use of symbols and the second is the desire to adopt e-labeling.

Use of symbols

The use of symbols in medical device labeling has been common for many years. In 1996, the European Union introduced legislation to provide some sort of harmonization to the use of symbols. The goal was to reduce the number of translations of words into the myriad languages used in the EU and in doing so, to simplify labeling. The result was the adoption of European Standard (EN) EN980, which was released in 1996 and modified in 2003 and 2008. There is also another standard called ISO 15223 that covers much the same material and EN 980, with some additional symbols.

By necessity, the Europeans have always been far ahead of the US in the adoption of symbols as a means of communicating basic concepts. In 2002, ten new countries joined the EU, adding even more languages to a Union that already included more than a dozen official languages. With so many languages, it became increasingly important to ensure the safety of the public and professionals and one way to do this was through the use of symbols to communicate important concepts such as Use By, Sterility, Temperature Limitation and so on.

Advantages of Symbols

Using symbols on your labeling offers several advantages. First, symbols reduce your costs. A symbol that shows "See Instructions for Use" takes up much less room than 20+ translations of the phrase! As we all know, the more you have to read on a package the less likely you are to read anything at all. Naturally, symbols also save space, and make your packaging and products more attractive. Most importantly, of course, symbols quickly communicate a concept to the user in a way that can transcend language if used properly.

Quite unfortunately, the driving factors behind the increased use of symbols have as much to do with safeguarding users as reducing the liability exposure the manufacturer. Problems arising from medical device user errors far exceed those from device failure, yet the manufacturer is certainly not absolved of responsibility when user error results in injury or death. Case in point, open an owner's manual for a lawnmower and there will be two pages telling you not to stick your hands under the mower while it's running.

Quite often a distributor will learn about potential problems caused by poor labeling before you do. It is important that companies have Standard Operating Procedures to make sure that any and all proposed changes made to labeling (especially those by distributors) are run through the QA and RA department first.

The US does recognize a handful of EN980 symbols, but only as they relate to IVD's for professional use. The FDA has been cautious in adopting symbols because they feel most of them are not clear enough to stand on their own without English text accompanying them.

It should be noted that the use of symbols is voluntary, but strongly encouraged in the European directives for medical devices. Furthermore, if one of the symbols in EN 980 or ISO 15223 does not meet your needs, you can create your own symbol as long as they are fully explained in the Instructions for Use. Example, no symbol for "Do Not Shake" exists in EN 980 or ISO 15223, so you could create one if desired. If you manufacture electrical equipment, you should also refer to EN 60601 for more information.

Growth of e-Labeling

E-Labeling has been a hot topic over the last few years for good reasons. Companies are exporting to more markets, growth ultimately fueled by the explosion of the internet as a communication tool. Plus, the EU now has 27 countries. This has driven the need to create ever larger Instructions for Use and more perplexing, a need to accommodate ever more languages onto limited packaging space.

Correspondingly, the cost of translating Instructions for Use and other labeling has driven many device manufacturers to look for cheaper ways to distribute that information in a manner that allows for cost-effective updating. The primary argument for e-labeling, aside from cost savings, is that the user will have the most up-to-date information at their disposal. Websites IFUs and CD-ROM also allow the manufacturer to demonstrate how their device is used in a way that static photos or illustrations cannot convey. A picture may be worth a thousand words but a video is worth a thousand pictures.

The current Medical Device Directive is somewhat confusing in addressing electronic labeling. It refers to a "leaflet" and requires the IFU to accompany the device. So is a CD-ROM packaged with a device allowed? Can the IFU refer a professional user to a website for instructions for Use or download onto an iPhone Blackberry? Not yet,but this will come eventually. Many manufacturers are supplementing the paper trail with these tools, a move generally supported by users according to surveys.

National regulatory agencies in Europe have been reluctant to embrace e-labeling and therefore the language in Directive 2007/47/EC does not explicitly say it is allowed, but does not rule it out either.

Best practices

In the final analysis, reducing the cost of your translations and printing should not be the driving factor in your adoption of symbols and, eventually, e-labeling. Safety is key. It is most important that you complete a risk analysis to determine what would happen if a user did not understand what a particular the symbol meant. Could injury or death result? If so, err on the side of also providing a translation of that symbol in the IFU. As for electronic labeling, supplement your paper based efforts if you feel it will add to the safety of your device for the user, or offer you a competitive advantage.

While you have a regulatory responsibility to ensure the safety of your products, you also have a moral responsibility as well.

Originally published in October 2006