Paper vs electronic IFU: costs and obligations for medical device manufacturers
Reviewed 7 October 2026 · Sources: EUR-Lex · By Scan & Care · Not legal advice
The short answer
Moving from paper to electronic instructions for use (eIFU) can remove the recurring costs of printing, reprinting and handling obsolete copies, but it does not remove the manufacturer's obligations. You still need a documented risk assessment, paper copies for lay persons and on request (within 7 calendar days), a compliant website and, where EUDAMED registration is mandatory, the internet address of the eIFU. Whether eIFU is cheaper for you depends on your volumes, products, languages and how often the instructions change.
Where do the costs of paper IFUs come from?
- Printing. Every pack carries a printed copy: packages × cost per copy, for every product and every language.
- Reprints and updates. Each change to the instructions can mean a new print run, new packaging artwork and a changeover on the line.
- Obsolete copies. Printed leaflets and packs already in stock or in the distribution chain may carry superseded instructions.
- Lost or damaged copies. A printed leaflet can get lost, damaged or separated from the device, and replacing it means another print and delivery.
- Translations and layout. Every language needs translation, review and typesetting. These costs also exist with eIFU, because the language requirements set by each Member State still apply.
- Storage and logistics. Printed material has to be stored, inserted into packs and shipped, and it adds weight and volume.
- Internal time. Tracking which version is in which pack and coordinating changes between regulatory, quality, packaging and production.
A simple way to estimate the yearly cost
A first estimate is: packages per year × cost per printed copy × number of products × number of languages × (1 + additional reprints per year). For illustration only: 50,000 packages at €0.10 per copy come to about €5,000 a year for one product in one language; 500,000 packages at €0.03 per copy come to about €15,000. The cost per copy usually falls as volumes grow, but the total remains a recurring cost, multiplied by products, languages and reprints. Use your own supplier quotes: the range of €0.01 to €0.10 per copy used in the Scan & Care calculator is only indicative. Try the calculator.
What does eIFU add?
- A platform and hosting that keeps the current version available, protected against unauthorised access and compliant with data protection rules.
- The risk assessment and its documentation, reviewed whenever the intended users, the environment of use or the access conditions change.
- A process for paper copies: a system to provide the paper version at no additional cost, within the time set in the risk assessment and at the latest within 7 calendar days of a request, and always for lay persons.
- Continuity: the risk assessment must cover the unavailability of the website and medical emergencies.
- Version history: every issued version and its publication date on the website, with obsolete versions available at least on request.
- UDI/EUDAMED: the internet address of the eIFU, where registration is mandatory.
- Label information telling users that the instructions are provided electronically and how to access them.
Paper and electronic IFU at a glance
| Paper IFU | Electronic IFU (eIFU) | |
|---|---|---|
| Recurring cost | Printing and insertion for every pack, repeated at each reprint | No printing for professional-use devices; platform, hosting and process costs instead |
| Updating the instructions | New print run and packaging changeover; obsolete copies may remain in circulation | The current version is updated online; the version history must be kept and published |
| Languages | One printed version per language and pack | Language requirements still apply; the user selects the version online |
| Access | Always with the device | Requires a device and a connection; the risk assessment must cover this |
| Risk of losing the instructions | The printed copy can be lost, damaged or separated from the device | Nothing physical to lose: the current version stays available online, as long as access is guaranteed (see the row above) |
| Paper copy | Included | At the latest within 7 calendar days of a request, at no additional cost; always for lay persons |
| Regulatory workload | Established process | Risk assessment, website requirements, EUDAMED address |
When is paper still the better choice?
- Devices for lay persons. Paper is required for instructions intended for lay persons, including when use by lay persons of a professional-use device is reasonably foreseeable.
- When access cannot be guaranteed. Where users may not have a device or a connection at the point of use, or in urgent situations, the risk assessment may point to paper.
- Very low volumes. If you ship few packs, the saving may not cover the platform and process costs.
Checklist before you switch
- Confirm that the device is intended exclusively for professional users and that use by lay persons is not reasonably foreseeable.
- Write and approve the risk assessment, including the unavailability of the website and medical emergencies.
- Set up how paper copies are requested and delivered within 7 calendar days.
- Check that the website meets the requirements: format readable with free software, protection, data protection, version history.
- Plan the label or packaging text that explains how to access the eIFU.
- Add the internet address of the eIFU to your UDI/EUDAMED data when registration is mandatory.
- Estimate the yearly paper cost you would remove and compare it with the platform and process costs.
Where Scan & Care fits
Scan & Care is a SaaS portal, hosted in the EU, to publish and update IFUs, leaflets and manuals as digital documents reachable through a QR code, with versioning, multilingual documents and paper-copy requests. It supports the operational side. It does not replace the manufacturer's regulatory assessment.
Start free for 12 months Calculate your paper costFrequently asked questions
Is eIFU always cheaper than paper?
Not necessarily. eIFU removes printing and reprint costs for professional-use devices, but adds platform, risk assessment and process costs. The result depends on volumes, the number of products and languages, how often the instructions change and what your current print runs cost.
Does eIFU remove the need for translations?
No. The language requirements set by each Member State for the information supplied with a device continue to apply. eIFU changes the format in which the instructions are provided, not the languages in which they must be available.
Can I use eIFU for some devices and paper for others?
Yes. The option applies device by device. A manufacturer can provide eIFU for devices intended for professional users and keep paper for devices intended for lay persons.
How quickly must a paper copy be provided on request?
Under Regulation (EU) 2021/2226 (Article 5(3)) the manufacturer must have a system in place to provide the paper version at no additional cost to the user, within the time set in the risk assessment and at the latest within 7 calendar days of receiving the request, or at the time of delivery if the paper copy was requested when ordering the device.
How do I estimate my paper cost?
Multiply packages per year by the cost per printed copy, the number of products, the number of languages and (1 + additional reprints per year). The Scan & Care calculator does this with your own figures.
Sources
- Commission Implementing Regulation (EU) 2025/1234 (EUR-Lex)
- Commission Implementing Regulation (EU) 2021/2226 (EUR-Lex)
- Regulation (EU) 2017/745 (MDR) (EUR-Lex)
This page is a plain-language summary for information only. The cost figures are illustrative examples, not quotes or promises of savings. It is not legal advice. Always refer to the official text and to your regulatory affairs adviser or notified body before changing how your instructions for use are provided.