eLeaflet™ by myHealthbox™ lets device and IVD manufacturers publish, update and distribute electronic Instructions for Use for every market from their own site at your-company.eifu.me. Fully managed or self-managed, on a platform validated against EU GMP Annex 11 and FDA 21 CFR Part 11.
Until 2025, Implementing Regulation (EU) 2021/2226 allowed electronic instructions for use for a limited list of medical devices only. Implementing Regulation (EU) 2025/1234 removed that limit: any MDR device intended for professional users may now ship with an eIFU instead of a paper leaflet.
The permission is already in force. What is left is the work on your side: a risk assessment, a compliant website, labelling that points users to it, and a way to deliver paper copies to anyone who asks for one.
A safety-relevant change means reprinting and repacking, while stock already in the field carries the old text.
One box for many markets means thick booklets, tiny print and every language revised in lock-step.
Different revisions circulate in different countries, and it is hard to prove which one a user had.
Printing, packaging volume and logistics add up for a leaflet that professional users often already know by heart.
The same eLeaflet™ platform that already distributes digital leaflets for pharmaceuticals, configured for medical device and IVD instructions for use.
Store, manage and distribute the IFUs for every product, market and language from one place.
Changes are reviewed and approved with electronic signatures in the myHealthbox™ editor. Once released, they are what users see.
Previous versions stay available, so users of older devices can still find the IFU that matches them.
QR codes, GTIN, GS1 DataMatrix and GS1 Digital Link take users from the label to the right document.
Publish localised IFUs for each market, and let users switch language without a second document.
Add images, video and audio next to the text where they make a procedure easier to follow.
Content is served over HTTPS and digitally signed, so users can trust that what they read is authentic.
Start with the PDF IFUs you already have. Move to structured formats such as HTML and XML (plus ePI and SPL if you also handle medicinal products) when you are ready.
Your eIFUs are published on your own address, ready to print on labels and packaging:
One stable link for every product, market and language. The site picks up each approved release automatically through the myHealthbox™ APIs.
Users can send customer enquiries and report device defects from the eIFU itself, in their own language.
Your products also appear on the myHealthbox™ search engine, so people searching for a product find its current instructions.
No extra publishing work: the same approved release updates your eifu.me site and your myHealthbox™ listing.
Your QA team will audit the platform before they rely on it. These are the answers we give them.
The platform is validated against the EU requirements for computerised systems.
Validated against the FDA requirements for electronic records and electronic signatures.
Designed to meet the eIFU website and availability requirements, as amended by 2025/1234.
The same platform has distributed regulated digital leaflets for medicinal products for 10 years.
The platform supports your compliance with the MDR and IVDR. The manufacturer remains responsible for its own eIFU risk assessment and labelling.
Whichever provider you choose, these are the questions that matter for users, for auditors and for your notified body. Here is where eLeaflet™ stands on each.
Both models run on the same validated platform. You choose how much your team does.
Send us your approved IFUs. Our team prepares, publishes and maintains them on your eIFU site.
Your regulatory or labelling team creates, approves and releases IFUs in the myHealthbox™ editor.
eIFU rules differ by device type, by user and by market. Here is the current picture.
| India | Allows eIFU as the primary IFU for many devices (CDSCO) |
| Vietnam, Thailand, South Korea | Allow lay-user eIFU under conditions (APACMed) |
| Australia | TGA has consulted on more flexible, digital IFU formats |
| Canada | Health Canada is evaluating digital IFU |
| Belgium (national initiative) | Agreements reference partial digital labelling |
Regulatory summary for information only. Confirm the requirements for your device class and markets with your regulatory advisers. Sources: 2021/2226 · 2025/1234 · IVDR 2017/746
Replace paper IFUs for professional-use devices now that 2025/1234 allows it.
Move professional-use IVDs to eIFU, and be ready if near-patient testing follows.
Serve each market under its own rules, including those already opening eIFU to lay users.
Tell us about your devices and markets. We'll prepare a demo around them.
We'll be in touch shortly to arrange your eIFU demo.