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Reducing Medical Device Packaging Waste and Improving Information Provision Through E-labelling

E-labelling offers patients and healthcare professionals the convenience of always having up-to-date information on their products, such as the latest safety updates. It also provides regulators with greater oversight and assurance that manufacturers are providing accurate and timely information. Dr. Jutta M. Hohenhörst, from Schlafender Hase, explores the benefits of e-labelling for the medical device sector and provides some practical tips for getting ahead with processes, procedures and solutions that deliver efficiencies and add value for patients.

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. This will take them to the latest details, in an easily digestible format – often including audio and video options now, for maximum accessibility.

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

E-labelling Benefits

E-labelling makes externally-facing product information more dynamic and immediately accessible online or through an app. That could be as a downloadable document, as 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, or healthcare providers) to access and digest – while also ensuring that the guidance is as up-to-date as possible.

Paper inserts (instructions for use – IFUs; or patient information leaflets – PILs) present a number of practical challenges that can be readily solved in the digital age. These include the risk of costly printed instructions being misplaced or damaged; poor accessibility due to very small print because the leaflets have to try to cover all bases; safety information being superseded; potential regulatory Requirements: Section 508 ( pdfs/) and European Accessibility Act.1

Regulatory Change Focused on Safety

Across many developed markets, the medical device industry is already subject to considerable regulatory change, geared to 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 which have seen a growth in both smart implanted and wearable devices, and 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 is being added all the time, around e-labelling. 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.