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New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.

In the consumer world, it’s now common practice to access product information online. For detailed instructions or information about manufacturing practices, safety advice and so on, users can scan a QR code or go to a web address, which takes them to the latest details, in an easily digestible format, often including audio and video options, for maximum accessibility.

Although the life sciences industry has some way to go to match these ‘e-labeling’ experiences, regulators are making moves to change this through new directives and guidance.

Asian markets and Australia are leading the way here, but the trend towards e-labeling and digital patient information leaflets (e-PILs)/instructions for use (e-IFUs) is moving east and west, with European and North American markets now promoting electronic alternatives to the folded physical inserts in tiny print that have traditionally accompanied medicinal and medical device products.

e-labeling makes externally facing product information more dynamic and immediately accessible online or through an app. This information can be provided as a downloadable document, a shorter-form searchable text, or in alternative formats such as audio- or video-based instructions. The idea is to make important information easier for users (patients, caregivers and healthcare providers) to access and digest, while also ensuring that the guidance is as up to date as possible.

Paper inserts present a number of practical challenges that can be readily solved in the digital age. These include:

Across many developed markets, the medical device industry is already subject to considerable regulatory change, geared toward improving device traceability and patient safety. These measures have been driven by high-profile safety events, such as the PIP breast implant scandal in Europe, and by advances in technology including a growth in both smart implanted and wearable devices, and an increase in combination products (devices and pharmaceutical products that work in concert).

EMA’s Medical Device Regulation and its in-vitro equivalent, IVDR, are among the updated sets of requirements designed to provide fit-for-purpose safety controls. And specific guidance around e-labeling is being added at a quick pace. In December 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 for the use of e-IFUs for medical devices, with application from January 2022. The Regulation adapts the conditions and requirements for going ‘paper free’ for manufacturers of medical devices, including software covered by EMA MDR/IVDR.

The term ‘e-labeling’ potentially understates the scale of change that will be involved as digital information delivery becomes the default for medical device product information and instructions for use. Appreciating this, EMA is phasing in e-labeling by target user group. For now, the provision to provide IFUs in an electronic format instead of paper form is limited to certain medical devices and accessories intended for use under specific conditions. These are devices used by health care providers and include:

A next phase will see digital resources, shared via web sites and mobile apps, extended to patients. The idea is to have a robust digital platform in place before eventually moving away from paper-based IFU inserts.

With patient safety and access to consistent information in mind, movements are afoot to ensure that e-labelling is harmonized around the globe, in line with international minimum standards. So, any investments made now will lay valuable foundations for eventual global delivery.

Operationally and reputationally, creators and suppliers of medical devices have much to gain by embracing e-labelling at their earliest opportunity. Potential benefits include:

The changes required to deliver these benefits will be felt widely, and require a joined-up approach to transformation to minimize the pain and maximize the numerous potential gains. Many of the operational gains are based on the increased accuracy of content (getting all aspects of labeling right first time).

Paper and electronic versions of content will co-exist for a time, ensuring that all medical device users can access the information they need in the way they prefer to digest it, to maximize patient safety. This overlap, as e-labelling is phased in, offers device manufacturers the chance to align and hone their content management with a view to gradually phasing out the reliance on paper, as device users become more comfortable interacting with online or app-based resources.

By beginning the process now, companies can take early advantage of processes, procedures and solutions that deliver efficiencies across today’s labeling landscape and add new value for patients. As medical device manufacturers prepare for a digital-first future, they will be rewarded with long-term improvements, such as:

These three essential capabilities of e-labeling give manufacturers the ability to transform accurate content into any format that can then be published in a physical or virtual form, as well as posted to competent authority databases. A pragmatic approach to this is likely to involve the application of intelligent proofreading software, which can identify any anomalies swiftly and reliably.

Underpin all of this with an integrated infrastructure and simplified processes with real-time controls, and manufacturers will be ready to fulfill any e-labeling requirements, avoiding the need for major 11th hour resource expansions and costs to meet impending deadlines.

If you are ready to move toward e-labeling capabilities, start with the end goals in mind and review all existing guidance, regulations and standards proposed by the Global Harmonization bodies to gain an understanding of today’s regulatory landscape and tomorrow’s potential. Then, take proactive steps to create and execute a coordinated e-labeling strategy and plan as follows:

Once the real work begins in earnest, devote time to defining the scope, objectives and key performance results, and monitor these on an ongoing basis. Finally, communicate and celebrate all wins to sustain momentum.

The explosion of e-commerce and mobile device use shows how quickly and dramatically shifts in consumer behavior can happen once new and convenient options are made available to them. Given the diverse benefits promised by e-labeling, it makes sense to be at the head of this trend.

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Peter Muller, Director, Americas at Schlafender Hase has worked on software and process improvement projects relating to proofreading with Fortune 500 companies from various industries: Pharmaceutical, Medical Device & Consumer Goods for over 25 years. He has a wealth of experience working with international clients to define their organization’s goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.