Everything the Manufacturer Must Tell You — in One Standard.
ISO 20417 strategy for information supplied by the manufacturer — the single standard that consolidates what your label and instructions for use must contain, harmonised so one content set serves multiple markets.
One Checklist, Instead of Requirements Scattered Across a Dozen Standards.
ISO 20417 gathers the general requirements for information supplied by the manufacturer into a single reference — the label and instructions-for-use content a device generally has to carry. It is the backbone your labelling is built against.
Manufacturer identity
The legal manufacturer, address, and, where relevant, the authorised representative.
Device identification
The name, model, catalogue number, and the UDI that ties it to the record.
Intended purpose
What the device is for, its indications, and any contraindications.
Warnings & precautions
The residual-risk information a user needs to use the device safely.
Instructions for use
How to use the device correctly — and when an IFU may be omitted.
Sterility & single use
Sterile state and method, and whether the device is single-use.
Dates & storage
Manufacture and use-by dates, plus handling and storage conditions.
Disposal & residual risk
Safe disposal information and any special handling the device requires.
ISO 20417 tells you what; ISO 15223-1 tells you how. The two are partners — 20417 defines the information to supply, and the harmonised symbols carry much of it without translation. Built together, one content set serves many markets.
Before 20417, ‘What Goes on the Label?’ Was a Search Across Many Standards.
ISO 20417 exists because the requirements for information supplied by the manufacturer used to be scattered — a clause here, an annex there, duplicated and occasionally in tension across device standards. The standard consolidates them into one reference, so the content of your label and IFU is defined in a single place rather than assembled by scavenger hunt.
That consolidation is the value: build your labelling and IFU to ISO 20417 as the master content requirement, layer the ISO 15223-1 symbols that carry it, and add the UDI, and you have a coherent, defensible labelling system — not a patchwork that a reviewer can pull a thread from.
20417 gathers the manufacturer-information requirements into one place — the content backbone your IFU is built on.
Six Disciplines That Carry an IFU and Label.
From the content requirements to the multi-market IFU that serves every jurisdiction from one source.
Content-Requirement Mapping
Your label and IFU mapped to ISO 20417’s consolidated requirements — the master checklist that ensures nothing required is missing and nothing is duplicated in tension.
Symbol & Language Strategy
The split between ISO 15223-1 symbols and required text, and the translation strategy — so one content set reaches multiple markets efficiently.
Instructions-for-Use Authoring
IFU written for the actual user in the actual environment — clear, complete, and usability-informed, not a legal document nobody can follow.
Multi-Market Reconciliation
ISO 20417 as the base, reconciled with FDA labelling rules and MDR/IVDR Annex I information requirements — one master, market-specific overlays.
Labelling Change Control
IFU and label content wired into change control — so a design or indication change updates the information the manufacturer supplies, every affected SKU.
Completeness Review
The full content set reviewed against ISO 20417 before a reviewer does — the check that turns a missing-information finding into a non-event.
Content, symbols, and identity are one label managed together — or three obligations that collide.
20417, 15223-1, and UDI Are Three Views of the Same Label.
The information ISO 20417 requires, the ISO 15223-1 symbols that carry it, and the UDI that identifies the device all live on the same label and in the same IFU. Managed separately they conflict — the content that assumes a symbol the layout can’t fit, the UDI that crowds out required text. Managed together they compose.
We build labelling as one system across all three, connected to labelling and usability — because an IFU is also a use-related risk control, and the information you supply is part of how safely the device gets used.
Six Failure Modes We Are Brought In to Prevent.
Most are a required element missing, or three standards managed as if they were unrelated.
A required element missing
An item ISO 20417 requires simply absent from the label or IFU — the finding with a consolidated checklist behind it.
Content scattered, not consolidated
Labelling still assembled from scattered standard clauses — duplicated, occasionally contradictory, and hard to keep current.
Symbols and content managed apart
An IFU that assumes a symbol the label layout never accommodated — 20417 and 15223-1 treated as separate projects.
An IFU nobody can follow
Instructions written as a legal shield instead of usable guidance — complete on paper, a use-related risk in practice.
Markets patched, not designed
US, EU, and other content maintained as separate documents that drift apart — instead of one master with market overlays.
Change that skipped the IFU
A design or indication change that updated the device but not the information supplied with it — a label that no longer describes the product.
Manufacturer Information, Built as One Coherent System.
Our labelling leads have mapped content to ISO 20417, authored multi-market IFUs, and kept them coherent with symbols and UDI.
“ISO 20417 ended the scavenger hunt for what goes on a label. Build to it as the master content requirement, and the IFU stops being a patchwork someone can pull a thread from.”
The discipline we bring to manufacturer information.
Is Everything the Standard Requires Actually on Your Label? Check It Against the Master List.
A senior labelling lead can map your label and IFU to ISO 20417, reconcile it across markets, and build it as one system with symbols and UDI — not a patchwork.
Senior-led. Embedded in your team. No junior hand-offs.