EU Seeks Public Input on Transition to Digital User Instructions for Medical Devices

The European Commission has initiated a public consultation regarding the shift to electronic user instructions for medical devices, referred to as electronic Instructions for Use (eIFUs). This consultation allows organizations and EU citizens to provide feedback on the proposed legislation over a four-week period.

The initiative aims to enable the use of digital user instructions for all medical products intended for healthcare professionals in their professional settings. A QR code will be affixed to the medical products or included in the accompanying documentation, granting access to the user instructions online.

The push for digital instructions aligns with the European Commission's long-term goal to facilitate the cross-border exchange of medical products and, eventually, pharmaceuticals within the EU. This need has become increasingly urgent due to ongoing supply chain disruptions. Brussels has indicated that the electronic format could potentially become mandatory as early as 2035.

As part of this consultation, EU organizations and the public are encouraged to review the draft legislation and submit their comments. The Commission has stated that it will consider this feedback in the finalization of the regulations.

The Federal Association of Medical Technology (BVMed) views the move to digital instructions as a significant advancement. The association highlights benefits such as reducing paper consumption, leading to smaller and lighter packaging. Additional advantages include the ability to select language preferences, search for product information using specific terms, adjust display sizes, and incorporate multimedia elements like videos and animations. Moreover, BVMed believes that maintaining up-to-date information will enhance the international competitiveness of European industries.

However, some responses to the EU's proposal have expressed concerns. A citizen from Germany noted the risks associated with fully replacing physical user instructions with digital versions. The individual emphasized the importance of having paper backups, particularly for critical items like medical devices, due to potential access issues stemming from system failures or cybersecurity incidents.

Currently, European regulations mandate that most medical devices include paper-based user instructions, which can often be extensive. Additionally, if a product is marketed in multiple EU countries, translations are required, further contributing to paper waste.

Pharmaceutical associations have also raised concerns. The Federal Union of German Associations of Pharmacists (ABDA) previously cautioned the Federal Ministry of Health (BMG) against replacing printed patient leaflets with digital alternatives. They argue that electronic instructions may not be a suitable substitute for paper versions, particularly for older populations who may struggle with digital access or usage.

Internationally, the World Pharmacists Organization (FIP) has called for the inclusion of pharmacists in any decision-making processes regarding electronic patient leaflets, stressing their expertise and ability to bridge the gap between regulatory authorities and patients.

Meanwhile, France is implementing a gradual approach to the introduction of electronic patient leaflets. The French government is piloting a project that will test the acceptance of digital versions among the public for one year, while still retaining the paper format for the time being. If the initiative proves successful, a full transition to a digital-only system may follow.