What is all the fuss about?

Over the past few years there has been an inclination in countries, regulatory bodies and local authorities requesting life science companies to display greater amounts of information on the labels of their medical devices and corresponding IFUs that are used only by medical professionals. Information spans from warnings and cautions to the types of materials used and even clinical data which then also needs to be translated into other languages. IFUs are becoming thicker, text is becoming smaller, more and more peel off labels are being added and if space for UDIs were in fact real estate, then their price would be through the roof. So what can you do as a medical device manufacturer to combat this ongoing challenge? You’ll just have to keep on reading…

What solutions are available for my business?

One option is to postpone labeling till a later stage. This is commonly referred to as “Late Stage Labeling” and involves printing labels and IFUs in the last stages of production. The challenge is timing; how to print and launch at the same time. Another option is to use your salesforce to monitor and provide IFU supplementary information. However, the cost involved in monitoring such an exercise is high and you may find yourself stretched for resources. Finally, depending upon regulatory requirements, you may be able to supply multimedia options such as CDs or DVDs, otherwise known as e-labeling. E-labeling as a means of distributing information within IFUs and labels has become a quick and practical solution for this ever-changing environment. 

Why move toward e-Labeling?

E-labeling is an electronic format of an IFU available the web. Changes to content or the implementation of additional industry/regulatory requirements can be implemented momentarily as e-labels are accessible via the internet, 24/7. Depending upon the regions your product is launching in, you may be able to simply update the online or electronic versions versus re-printing costly, hard-copy versions. As a company you will also reduce your ecological footprint on the globe by eliminating the need for paper used for printing and shipping.

There is increasing interest and compliance by countries around the world to also adopt e-labeling. The possibilities of what can be done to simplify and streamline the accessibility of labeling information is endless. Technology is bringing businesses and the end consumer closer together, through the use of mobile apps, QR codes and UDI links to share such information. This method of distributing information is paving a path of change as to how medical device manufacturers will react to industry or regulatory changes. Information can reach medical professionals across the globe, instantly, allowing for better patient care.

Get familiar with e-Labeling

If you decide that now is the right time to start integrating e-labeling into your content process, the first step is to assess your target countries and their individual regulatory requirements surrounding this type of information transfer. Not all regions allow for a complete overhaul or switch to e-labeling, but many do, and this could save your company time, energy and money.   

Here are a couple of guidelines to get you started!

E-labeling in Canada:

• You must notify Health Canada of your intention to provide e-labeling to goods either imported or sold to Canada
• You can only choose one electronic form – CD/DVD vs Internet
• The content on the labels must be the exact replica of the paper version

E-Labeling in the EU:

• Only applicable for implantables and implantable accessories, fixed, installed medical devices and software
• Must be approved by a Notified Body
• It must comply with EU customer privacy regulations
• Customers need to be notified on either a label of leaflet on how to access the information online
• A paper version must still be made available upon a customer’s request

How can your Language Service Provider help you prepare and implement e-labeling?

First and foremost, having an open and collaborative partnership with your Language Service Provider is key.  From there, these types of business decisions can then flow seamlessly into the translation workflows.

Your Language Service Provider (LSP) will work with you to design and implement a localization and translation program to ensure the success of your content transition to e-labeling. The purpose of e-labeling is to properly communicate to the end user the right way to use your products. It is important that your LSP knows which products and their corresponding documentation will be e-labeled and into which languages.

When it comes to distributing highly technical, medical content, Argos is here to help.  With our proven strategic life science partnerships and processes, we are ready to help you get started on the migration of your e-labeling information. 

Want to find out more about e-labeling? Then watch our webcast on E-labeling for Medical Device Manufacturers.