The digitisation of healthcare is progressing across the European Union and one of its concrete manifestations is the possibility of providing electronic instructions for use (eIFU) for medical devices. This replaces traditional printed manuals, simplifies logistics and makes information more digitally friendly for users.
However, the field is strictly regulated, and manufacturers must follow clearly defined rules. The framework currently in place is that of Commission Regulation (EU)2021/2226, which replaced the original 2012 regulation as of 4 January 2022. At the same time, the European Commission is preparing a further amendment, the draft of which is currently under public consultation.
The previous legislation (Commission Regulation (EU) No 207/2012) allowed the replacement of paper instructions by electronic ones only in very limited cases and exclusively for professional users.
The new regulation expands the possibilities of using eIFU, especially in the field of medical software, which is intended not only for professionals but also for ordinary users. Only electronically, manufacturers can now provide instructions if they meet the strict conditions set out in the legislation. The emphasis is on safety, accessibility and clarity of electronic instructions.
Key requirements include:
- A printed version can be delivered (the printed manual must be delivered free of charge to the user within 7 days upon request).
- Web platform (the electronic instructions must be published on a stable, secure manufacturer’s website).
- Notification of changes (users must be informed of any updates to the eIFU by electronic means (e.g. notifications or email)).
- Language requirements (electronic instructions must be available in the official languages of the Member States where the product is marketed, in accordance with the rules of the Medical Devices Regulation).
The forthcoming amendment: even more flexibility?
The European Commission is currently preparing a revision of the eIFU Regulation, a draft of which is available on the “Have your say” portal as part of a public consultation.
The aim of the planned modification is:
- Extend the use of eIFU to other types of medical devices,
- Align eIFU requirements with current digital standards and accessibility guidelines,
- simplify administrative requirements for manufacturers,
- take into account experience from practice and feedback from patients and healthcare professionals.
At the same time, it will be assessed whether the current regime adequately protects users’ rights and whether the current scope of the information obligation towards lay users needs to be changed.
Summary for practice
Electronic guides are a useful tool for modern medical documentation, but their use remains subject to strict rules in the EU. Manufacturers of medical devices must ensure not only technical security of access to the instructions, but also compliance with the requirements for language versions, retention of historical versions and timely notification of changes to users. The forthcoming amendment of the Regulation gives hope for further simplification of practice, especially in relation to software and hybrid devices.
It is therefore recommended to regularly review current regulatory developments and to prepare internal mechanisms that will allow flexible implementation of future changes without unnecessary delays.
If you would like more information in this regard, please do not hesitate to contact us.
This article is for informational purposes only and does not constitute legal advice or guidance for any particular case.