In less than a year, in March 2013, the European Union (EU) e-labeling regulation will come into full force. Whether companies love it or hate it, the regulation represents an important path toward modernizing labeling. The regulation also opens the potential for improved safety and increased efficiency.
However, this potential is not without challenges and opportunities for helping clients move toward incorporating the regulation. The regulation has actually been in motion for some time. In 2007 a tiny change in the regulation text from “accompany” to “be provided” opened a window of opportunity: it allowed that labeling could be something other than the traditional print format.
Four years later, in June 2011, the European Commission issued a draft regulation on e-labeling for medical devices. Then in September 2011, the final draft version of the Regulation was sent for adoption. The draft was adopted in March 2012. Companies have had about 12 months to understand and tease out the implications of the new regulation. As you might expect, the final regulation limits e-labeling to medical devices defined as “professional use only,” along with those accessories also intended for use in specific conditions. The draft is very specific about the conditions in which Instructions for Use (IFUs) may be provided electronically rather than in paper format.
Given the risk-averse medical device industry, the potential for risk tops the list of conditions to watch for when preparing for a change in labeling. The regulation requires a manufacturer to document its risk assessment as a necessary precautionary measure. This risk assessment must demonstrate that the use of electronic instructions will maintain or even improve patient safety compared with paper-formatted IFUs. In fact, the regulation requires the risk assessment be updated further with information and experience gained from the post-market surveillance phase. After documenting the risk assessment, the regulation includes a number of safeguards for the end user, which include:
Creating an on-demand system to make printed IFUs available on request at no additional cost to the user. This system must account for the time period for delivery of instructions noted in the risk assessment (less than seven calendar days).
Providing an alternative IFU website repository. Even when delivered with or within the device electronically, manufacturer websites must meet specific requirements — for instance, ensuring users have access to all previous versions for use in their electronic form and their date of publication.
Protecting personal data that individuals might provide when accessing IFU information on a website.
Providing a system to indicate when an IFU has been revised. The system must tell each user of the device if the revision was necessary for safety reasons.
The benefits of e-labeling are fairly intuitive: e-labeling allows the medical device industry to pull together technology, regulatory approval and customer acceptance in a viable, cost-effective and care-effective communication option. E-labeling has the potential to improve patient safety with a more efficient method for storing, controlling and distributing information. E-labeling can also reduce time-to-market for new and revised information. And e-labeling can also reduce the medical device industry’s environmental footprint by reducing printing, shipping materials and costs. End users will benefit from e-labeling’s technical features such as integrated animation. These and other features have the potential to reduce the risk of misinterpretation. But there are challenges.
There are a few difficult-to-predict variables that surround how the end user engages with the IFU. A major concern is how e-labeling shifts responsibility from the manufacturer to the user: the end user must now take action to retrieve the labeling information versus passively receiving a printed piece. Maybe that action looks like loading and printing a CD-ROM. Maybe it means visiting a secure website or using a mobile device. The knowledge and experience of the intended user magnify the complexity and potential risks of this challenge.
For instance, what access do users have to electronic resources? Will users have unlimited access to electronic resources? If there are limits, what different ways will the information be made available? The information must be available to the right users but with only the necessary levels of security, to ensure the information is easy to access but also secure. Also, provision must be made for a thorough backup of information, including redundant information. Paper is required for emergency situations. What emergency situations might require quick access to the information or IFU?
Manufacturers rushing to meet the demands of the regulation may be tempted to hurry past needs that are somewhat less visible. This presents an opportunity for prospective firms that partner with these manufacturers racing toward e-labeling. They can help by clearly identifying the user’s needs and capacities. Surveys and other forms of market research, along with qualitative and even anecdotal information can supplement the manufacturer’s initiatives and processes.
Partners can help remind manufacturers to look broadly at how the user engages. Partners with translation and localization pedigrees can answer that question on multiple local fronts as well. This is the precision manufacturers need in order to answer the question of engagement. It is also the answer that will help users get the most from e-labeling.
Clearly indicating when IFUs have been revised is a must for all manufacturers. The regulation imposes a mandatory vigilance obligation because manufacturers must inform each user of the device of all IFU revisions — especially if the changes were necessary for safety reasons. However, the mandate does not state (or give any requirements) about how users should actually be informed. This is the challenge.
Informing users of revisions could be difficult because of the many factors to consider. What sort of notifications are required and to whom must they be provided? Is it an opt-in system? A system of web-based registration? Should notifications go out by standard, physical mail, and if so, how do you ensure it’s been received? Meeting these challenges requires basic definitions about who gets what information and when, and will likely be in flux over time.
The opportunity for partnering organizations is to recommend communication language, methods and channels that specifically make sense for each manufacturer’s sets of users. Localization experts will prove invaluable at drilling down to identify each market’s dominant languages, identify which methods will yield the best results when communicating with the target audience and bring to the discussion the market idiosyncrasies collected from their local channel contacts.
Partnering firms that have opportunity to respond to revision notification messages as they develop will help make the initiative concrete. But this can only happen if partnering firms have early and upfront access to the manufacturer’s process. This upfront investment helps make the initiative as efficient and effective as possible.
Unless justified by the outcome of the risk assessment, e-labeling must be handled the same for each member state. After all, if labeling is not consistently accessible, viewable, sharable or explicable by all users, it cannot fulfill its purpose of making products safer and easier to use. Partnering organizations can help by comparing the manufacturer’s proposed e-labeling process with the state of language and communication infrastructure in each EU member country. Due diligence in analyzing risk will prove useful for the e-labeling initiative.
The regulatory world turns slowly while technology moves quickly. Companies moving toward technologically-enhanced labeling solutions today face far different options and capabilities compared to three to five years ago.
Implementing an e-labeling initiative is a complex task, especially when working across departments such as information technology, regulatory and legal. While one team may have thought long and hard about the move to e-labeling, and even worked through the details and formed conclusions, colleagues in other departments may not have given it a thought. It is critical to consider all the stakeholders involved in the e-labeling decision-making process, to create a clarified e-labeling message, and to make sure the timing is known and understood.
The opportunity for those partnering with manufacturers is to be a voice of reason and to provide an informed, third-party perspective, both on the details of the regulation as well as the impact on customers.