Product mapping
A file link alone does not verify the associated product. Check the document mapping against the product reference and record in the portal.
eIFU GUIDE FOR MANUFACTURERS
What is eIFU?Electronic instructions for use.
A practical introduction for medical device manufacturers
eIFU stands for electronic instructions for use: instructions supplied in an electronic format. A document portal is one way to give users access to the published instructions associated with a product.
Manufacturer guide · Updated 6 October 2026
Plan your eIFU workflow around three decisions
- 01
Products and intended users
List products, intended users and target markets. Ask your quality and regulatory teams to assess eligibility for electronic delivery for each product and market.
- 02
Documents and publication
Map document types, revisions and required languages. Assign responsibilities for preparation, independent review, approval and publication.
- 03
Access and continuity
Plan how users find a product, open its documents and request support or a paper copy when needed. Check access links and updates.
PDF hosting vs controlled eIFU publication: what is the difference?
PDF hosting makes a file available through a link. Controlled eIFU publication manages that file together with its product, document language, revision and publication scope. A PDF can be an eIFU file format; a working download link does not establish that the workflow is complete.
Example: one product, a new revision
SAMPLE-001 is a fictional product reference. English IFU Rev. B is prepared after Rev. A has been published. The behaviour described here concerns the eIFU Systems workflow; it is not a feature assessment of every file hosting service.
- 01
Add the file
Uploading Rev. B does not make it the current published IFU. Check document type, language and product mapping.
- 02
Control publication
Preparation, independent review, approval and publication are separate decisions. Verify the published revision for the relevant product, audience and country scope.
- 03
Test the user journey
Use the product link to check access to Rev. B in the selected language. Rev. A is recorded separately in history; previously downloaded PDFs are not automatically removed from a user’s device.
Compare six parts of the workflow
Current revision
Replacing the content at a file address does not create an approval history. Distinguish the current published revision from previous and withdrawn revisions.
Language and scope
An available English file does not mean all required languages are ready. Check product, audience, country and file language together.
QR continuity
A QR can link directly to a PDF or to a product page. Managing the product link separately from revisions can support updates without replacing the printed QR; the domain and mapping must remain available.
Paper copy requests
A downloadable file does not show that a paper copy request has been fulfilled. Track the request, owner, dispatch and provision records separately.
Access records
A view or download record does not prove that a user has read or understood the instructions. Treat these records as access indicators.
Direct answers about file hosting
Can a PDF be an eIFU?
Yes, PDF can be a file format used for electronic instructions. Device eligibility for electronic delivery and the relevant workflow requirements must be assessed separately.
Is linking a QR code directly to a PDF enough?
A QR makes access easier. It does not by itself provide correct product, revision and language selection, updates, support or the relevant paper request workflow.
Can a shared folder replace eIFU software?
A folder can support file sharing. Assess which additional controls your workflow needs for product mapping, controlled publication, language coverage, history and requests.
Does an eIFU portal allow electronic instructions in every country?
Setting up a portal does not establish eligibility. The manufacturer’s quality and regulatory teams must assess product, intended user and document language requirements for Türkiye and other target markets.
Assess your current file workflow in four steps
- Show which file is current for one product and who approved that decision.
- Test what the user sees when the requested document language is unavailable.
- Check the product and file opened by a printed QR after a revision change.
- Trace the owner and fulfilment record of a paper copy request.
Supplier demo questions for software selection →
Product QR and document link guide →
Discuss your PDF and document publication workflow ↗IFU, eIFU and QR codes: the difference
IFU means instructions for use; eIFU describes their electronic delivery. A QR code is an access tool that can link to a document or product page. Creating a QR code alone does not verify the content, select the correct revision or establish eligibility for electronic delivery.
Can every device replace paper instructions?
There is no automatic exemption. Under the EU framework, device scope, intended users and applicable conditions must be assessed together. The 2025/1234 amendment expanded the scope for professional users; instructions intended for non-professional users remain subject to paper requirements. Use the current text and relevant market requirements for your product assessment.
Official sources and scope
Updated 5 October 2026. EU references below concern the EU framework; assess Türkiye and other markets separately.
Frequently asked eIFU questions
Does uploading a PDF complete an eIFU workflow?
A PDF can be a format for an electronic document. Product mapping, the approved revision, language coverage, access and support also need to be planned.
Does eIFU software guarantee regulatory compliance?
Software supports document and publication workflows. Decisions about product eligibility, content accuracy and market obligations remain with the manufacturer’s responsible teams.
Are English instructions enough for every market?
Document languages depend on target markets and intended users. Offering English access does not replace other required language versions.
LET’S DISCUSS YOUR REQUIREMENTS
See the platform with your team.
We will walk through document access, revision management and multilingual publishing around your product range and markets.
Chat on WhatsApp ↗DEMO REQUEST