How to choose eIFU software: a checklist for medical device manufacturers
Reviewed 7 October 2026 · Sources: EUR-Lex · By Scan & Care · Not legal advice
The short answer
Choose eIFU software in two steps. First check that it lets you meet what Regulations (EU) 2021/2226 and 2025/1234 require of the website that provides the instructions: a format readable with free software, protection against unauthorised access, data protection, every version with its publication date, availability and a way to supply paper copies. Then compare the day-to-day criteria: languages, QR codes, update workflow, roles and audit trail, import, support and pricing. The obligations stay with the manufacturer: no software makes you compliant by itself.
Step 1: what the regulations require
The regulations do not describe software products; they describe what the manufacturer must provide. These are the questions that follow from them.
| Topic | Question to ask the vendor | What a good answer looks like |
|---|---|---|
| Readable format | In which format are the documents published? | A format that can be read with free software, without a paid reader or plug-in. |
| Protection | Who can publish or change a document, and how is it protected against unauthorised access or alteration? | Named roles, access control and a record of who changed what and when. |
| Data protection and hosting | Where are the data hosted and how is GDPR compliance handled? | Hosting location stated, a data processing agreement available, and personal data of people who request paper copies handled as the GDPR requires. |
| Version history | Are all issued versions kept with their publication date? Can obsolete versions be retrieved? | Every version stored with its date, the current one clearly marked, obsolete versions available at least on request. |
| Availability and continuity | What happens if the service is unavailable? What backups and recovery measures are in place? | Backups, monitoring, a stated availability target and information you can use in your risk assessment. |
| Paper on request | How are paper copy requests received, tracked and fulfilled? Can you meet the 7-calendar-day limit? | A request channel, a log of requests and deadlines, and a clear way to fulfil them at no extra cost to the user. |
| EUDAMED address | Is the internet address of each eIFU stable? Does it stay the same when I update a document? | Permanent addresses that do not change with each upload, so the address you give to EUDAMED stays valid. |
Step 2: day-to-day criteria
These are practical criteria, not requirements of the regulations. Weigh them according to your situation.
- Languages. How many languages per product can you publish, and can users switch language easily? The language requirements set by each Member State still apply.
- QR codes. Can you generate QR codes that keep working when you update a document, and print them at the quality your labels need?
- Update workflow. How do you replace a document, who approves it and how do users always get the current version?
- Roles and audit trail. Can you separate who writes, approves and publishes, and see a log of changes?
- Many products. Can you import products and documents in bulk, and give consultants or colleagues limited access?
- Exit. Can you export all documents, versions and history, and what happens to the published addresses if you leave?
- Support and onboarding. Who helps you set up, and in which language?
- Pricing. Is pricing public, and what are the limits on products, documents and languages?
Red flags
- A promise that the software 'makes you compliant' or is 'MDR certified'. Compliance is the manufacturer's responsibility.
- Addresses that change with every upload.
- No version history, or no way to retrieve an obsolete version.
- Documents that anyone in your team can overwrite without a record.
- No clear answer on where the data are hosted.
- No process for paper copy requests.
- No way to export your documents.
Run a short pilot
- Pick 2 or 3 real products, including one with several languages.
- Publish the documents and check the QR code on a printed label.
- Replace a document and check that the old version is kept and the current one is shown.
- Send a paper copy request and see how you would answer it within 7 calendar days.
- Check the address you would give to EUDAMED and that it does not change when you update a document.
- Export everything and review it.
- Score each criterion (met, partly, not met). Treat the regulatory questions in Step 1 as must-haves and the others as weighted preferences.
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 and does not replace the manufacturer's regulatory assessment. Some services listed on our pricing page, such as print on demand, certified translations and label generation, are not yet available. Judge any provider, including us, with the checklist above.
Start free for 12 months Calculate your paper costFrequently asked questions
Is there a certified eIFU software?
The regulations place the obligations on the manufacturer and do not describe a certification scheme for eIFU software. Treat claims that a tool 'makes you compliant' with caution and check the criteria above. What a provider can do is give you the documentation you need for your own assessment: on paid plans, Scan & Care makes the platform validation documentation available in the portal.
Can I host the eIFU on my own website instead of a dedicated platform?
In principle yes. The obligations concern what the website provides: a readable format, protection, version history, availability and data protection. A dedicated platform such as Scan & Care simplifies the process considerably by handling the operational side: publishing, versions, QR codes and paper-copy requests.
Why does the stability of the address matter?
Where EUDAMED registration is mandatory, manufacturers must provide the internet address of the eIFU. An address that changes, or that belongs to a provider you later leave, creates avoidable work.
How long should I keep old versions?
Keep them for as long as your regulatory obligations and your notified body require for your devices. Check the retention period that applies to you before choosing where the archive lives.
Can I try software before committing?
Yes, and you should, using real products. Scan & Care offers 12 months free for up to 5 products.
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 checklist for information only. It is not legal advice and not a comparison of products. Always refer to the official text and to your regulatory affairs adviser or notified body before changing how your instructions for use are provided.