Electronic Instructions for Use (eIFU)

Publish current, localized device instructions to every patient and clinician from a unified product record, with audit-ready, fully change-controlled versions.

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Global Compliance Demands Localized, Change-Controlled IFU Data
What Is Electronic Instructions for Use (eIFU)?
Electronic instructions for use (eIFU) are digitally published, regulated documents that deliver localized, version-controlled device instructions to patients and clinicians in every market where a product is sold. Global regulations, including EU MDR, Regulation (EU) No 2021/2226, and Japan's PMD Act require full revision traceability and controlled access by region and language. Propel manages eIFU natively within the product BOM and change control process, giving modern manufacturers a single source of truth.
Localized Accuracy
IFU content filtered by region, country, and language ensures patients and clinicians always see the valid, current versions for their specific market.
Change-Controlled Revisions
Every IFU version lives inside the change control process, so the approved IFU document and its full history move with the product record automatically.
Audit-Ready Compliance
With IFU documents tied to the product BOM and controlled under 21 CFR Part 11 electronic signatures, every version is traceable for any regulatory inquiry.

Propel Connects eIFU to the Entire Product Lifecycle

One Authoritative Record
Product records in Propel carry native eIFU metadata fields including region, language, portal publish flag, and linked document, so the source-of-truth item record drives what is published externally. One change in Propel updates the portal, which every patient and clinician has access to see.
Controlled Global Publishing
Propel renders only valid, current IFU versions to the portal based on region, country, and language criteria. Patients and clinicians always have access to the right localized document without manual filtering or custom web infrastructure.
Change and Compliance Wired In
IFU versions move through Propel's change control process, with electronic signatures meeting 21 CFR Part 11. Every approved version is retained as a controlled document, keeping full history accessible for EU MDR audits, FDA inspections, and global product registrations.
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More Capabilities
Electronic Records and Signatures
Branded, Access-Controlled Portal
Change Orders
Device Master Record Documents
Global Product Registration
Electronic Records and Signatures
IFU versions are approved with FDA 21 CFR Part 11-compliant electronic signatures, creating a defensible audit trail for every change. Approval workflows enforce that the right stakeholders sign off before any version goes live.
Branded, Access-Controlled Portal
Establish a branded, permission-controlled external site where patients and clinicians can access current, localized IFU documents. Content is driven directly from the controlled product record rather than a separate, disconnected CMS.
Change Orders
IFU updates move through Propel's closed-loop change-controlled DCO and ECO process, ensuring every version is reviewed, approved, and released with full traceability before it reaches the published site. Change history is retained automatically for ongoing regulatory review.
Device Master Record Documents
IFU files are configured as controlled DMR documents in Propel, with each approved version tracked and change history retained. This structure supports 21 CFR Part 820 practices and keeps device documentation audit-ready at all times.
Global Product Registration
Propel tracks, maintains, and renews product registrations across global markets within the same system managing eIFU obligations. Teams can confirm market clearance before publishing IFU content to a new region, keeping commercialization and compliance tightly aligned.
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FAQ
How does Propel ensure patients and clinicians always see the correct, current IFU versions?
Propel filters published IFU content by region, country, and language directly from the controlled product record. When a new version is approved through the ECO process, the Community IFU Portal reflects the update automatically, so the right localized document is always current for every market without manual intervention.
Which regulations does Propel's eIFU capability address?
Propel's eIFU solution is designed to support Regulation (EU) No 2021/2226, EU MDR Regulation (EU) 2017/745, and MEDDEV 2.14/3, and Japan's PMD Act. Electronic signature support for IFU approvals also addresses FDA 21 CFR Part 11 requirements, so US and international regulatory obligations are covered.
Is eIFU available as a standalone add-on or only as part of a larger package?
Propel delivers eIFU as part of the Medical Devices Compliance Extension Package, which also includes Global Product Registration and digital FDA MedWatch submissions. It is also available as a standalone add-on for manufacturers who need targeted eIFU compliance without the full bundle. Learn more.

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