Medical device instructions for use, drafted from your technical documentation and risk file

An IFU is regulated labelling. Its intended purpose has to match the technical documentation word for word, its warnings have to come from the risk management file, and its symbols have to match the label in the box. INKFLOW drafts medical device instructions for use from the documents your regulatory and design teams already control.

Name the device in the brief and the writer works from guidance for medical device IFUs. It asks for device identity and UDI-DI, classification and target markets, intended purpose and users, residual risks and warnings, clinical benefits and performance, materials and sterility, the validated use steps, reprocessing parameters, specifications, label symbols and the addresses of the economic operators.

In plain terms: the draft is written from your approved data, missing values are placeholders, and the IFU must go through your own regulatory affairs and clinical review before release. It does not certify compliance with the MDR, UK rules or FDA requirements. INKFLOW is independent; it is not a notified body, an approved body or a regulator, and responsibility for the content stays with you as manufacturer.

Start a device IFU

Medical device IFU drafting, in four hand-offs

1
Identify the device and markets
Device name, models, catalogue numbers and UDI-DI, the classification, and whether it is for Great Britain, Northern Ireland, the EU, the US or several, since each sets its own content.
2
Release the controlled text
Intended purpose, indications, contraindications, users and patient population exactly as in the technical documentation, and the residual risks the risk file says users must be told about.
3
Supply the use and reprocessing data
The validated use sequence, ideally from usability engineering, with figures; cleaning, disinfection and sterilisation parameters with cycle limits; or the reasons a single-use device must not be reused.
4
Regulatory and clinical review
Payment follows a quote you can read first. The draft carries a sign-off page; your regulatory affairs and clinical reviewers check it against the file and approve it under your document numbering.

What the instructions for use cover

Warnings that trace to risk controls

Each warning or precaution is tied to its source in your risk management file, so a reviewer can see why it is there.

Preparation before use

Inspection, assembly, calibration and sterile pack checks, with what to do if the packaging is damaged.

Steps users were tested on

Numbered use steps that follow the sequence your usability work validated, with figure references from your drawings.

Reprocessing, or a clear single-use statement

Validated parameters and cycle limits for reusable devices; for single-use devices, the known risks of reuse as your file states them.

Specifications and IT requirements

Technical data, EMC and environmental limits and, for software or connected devices, the version and minimum IT security requirements.

Symbols and addresses

A glossary of the ISO 15223-1 symbols on your label, manufacturer and representative addresses, and how to report a serious incident.

IFU rules the draft follows, and the decisions it leaves to you

In the EU the Medical Device Regulation sets out the information that must accompany a device; Great Britain and Northern Ireland currently follow different routes; in the US, FDA labelling rules apply. The draft follows the markets you name. Whether a statement will satisfy a notified body or a regulator is decided in your review, not by the writer.

Clinical performance claims appear only as your clinical evaluation states them. INKFLOW will not round an accuracy figure, widen an indication or soften a contraindication.

Questions

Can it write an electronic IFU?

It drafts the content. Whether an electronic IFU is allowed for your device depends on the rules for your markets and device type; your regulatory team decides, and the text works either way.

Can one IFU cover several models?

Yes, if the differences are clear in your data. A value that varies by model and is not stated for each one is left as a placeholder.

Will it write the label as well?

This kit drafts the instructions for use. Label artwork and symbol selection come from you, and the IFU glossary is built to match them.

Can a reviewer with regulatory experience check it?

Request a quote for a human reviewer when ordering. You will hear back with a quote, and there is no charge for it unless you say yes.

Do prices include VAT?

Prices include any VAT; nothing is added at checkout.

We are an organisation. How can we pay?

Single orders are paid by card at checkout. For subscriptions and repeat orders, care homes, councils and businesses can ask about paying by Direct Debit or standing order at app.inkflowstudio.org/organisations.

More from INKFLOW

A patient information leaflet writer for discharge and self-care advice Clinical SOPs and NHS-style policies User guides and quick start guides for laptops AI technical manual writer Complete books and series Everything INKFLOW writes