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Navigating E.U. E-Labeling Regulations


Electronic Labeling (e-labeling) has the potential to be hugely beneficial to medical device companies creating Instructions For Use (IFU), labels and packaging information. But at the same time, the European Union’s 2012 e-labeling directive can be difficult to navigate.

The regulation came into full effect in March of 2013, giving medical device companies roughly a year to understand the new rules. Although e-labeling can cut costs and improve patient outcomes, navigating e-labeling compliance can be challenging.

However, there are steps companies can take to make sure their e-labeling practices are not only in compliance, but also favorable to patients and end users.

Cost Savings and Better Access to Information

E-labeling refers to medical device suppliers creating electronic IFUs, device and packaging information. The method does away with the traditional practice of creating this documentation on paper. Having these documents in electronic form means information can be continuously updated and companies are able save money otherwise spent on printing and distribution costs.

The 2012 E.U. directive requires a documented risk assessment from companies along with a number of practical safeguards, including:

  • Printed IFUs must be available at no cost and on request
  • Previous versions of IFUs must be available for use in their electronic form
  • User data must be protected
  • Users must be made aware when an IFU is revised or updated

The “Big Three” Challenges

The new directive aims to improve information control, create faster processes and enhance patient care. But, in order for medical device companies to get up to speed, they’ll face three main challenges.

First, the regulation puts more emphasis on a user’s ability to access information for a device. This means data security, access and the backup of information all need to be accounted for. It’s no longer simply a matter of packing the document with a device.

The second challenge is putting in place a revision notification strategy. There is no getting away from letting users know when revisions have been made, but it’s a challenge for suppliers. This poses a few questions: Who gets a notification? How do they get it? And what sort of notification is it?

Finally, the E.U. regulation explains that e-labeling methods must be accessible in all E.U. member states.

Five Steps to Streamline the Process

Although the E.U.’s e-labeling regulations pose challenges for medical device companies, there are actions that can be taken to create a successful initiative. The following six strategies can help ensure better processes in information control and distribution, faster processes and improved patient care:

  1. Create an ROI Analysis: A cost-benefit analysis is a primary tool for weighing current costs against the costs and benefits of e-labeling. For products currently in the marketplace, what are the pros and cons of moving to e-labeling based on the expected lifecycle in the marketplace and scheduled revisions? Products expecting few updates may be managed best with traditional labeling, while e-labeling might be beneficial for those expecting a number of revisions.
  2. Seek User Feedback: It’s important to get a good sense of what clients think about this new practice. Are they comfortable with it? Are they knowledgeable? The more comfortable they are with the method, the better.
  3. Assess Your Technology: Having a strong Content Management System (CMS) to manage your e-labeling projects is a good idea. A good CMS provides a single-source resource for managing massive amounts of content, including labeling revisions and updates. Does your company have access to this type of technology? If not, would it be feasible to obtain it?
  4. Plan for Long Term Data Revision: The E.U. regulation imposes strict revision notification and data retention obligations. Creating a strategy to manage these revisions is paramount to a successful transition from paper to e-labeling.
  5. Keep an Eye on The Competition: It’s important to know what your competitors are doing. If they’ve jumped onto the e-labeling train, it’s probably a good idea for you to do the same to keep up.

Don’t Underestimate E-Labeling’s Complexity

In the end, creating an e-labeling campaign isn’t an easy endeavor. The obstacles associated with e-labeling usually revolve around underlying problems of process. If hiccups in a company’s operations are addressed before the launch of e-labeling materials, things will be much easier down the road.

A collaborative approach across company divisions – including service partners, technology and regulatory groups – usually helps with developing and executing a successful plan.