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Intended use

Answer ten short questions and get an intended use statement you can edit and copy, with the points where your wording commits you to evidence.

  1. 1Readiness check
  2. 2Intended use
  3. 3Class and route
What kind of device is it?

This decides which standards apply.

What does it do for the patient?

Pick the main purpose. A device can do more, but the statement leads with one.

What exactly?

Name the thing it measures, finds, treats or is used for. Be specific: the narrower it is, the less you have to prove.

For example: , ,

In patients with which condition?

Optional. Leave it out if the device is for anyone.

Which patients?

Name only the ages you will have evidence for.

Who uses it?

The person who operates it, not the person who buys it.

Where is it used?

Pick the main place. Add others in the statement later.

How does it touch the body?

Pick the most invasive answer that applies.

What do you call it?

Optional. A working name is fine.

Send this to IF MedTech →

Sending opens our enquiry form with this result already in it. Nothing is sent until you press send there.

How this works

Why it comes first

Under the Medical Devices Rules, 2017 the class follows the intended use you state. The tests, the clinical evidence, the label and every claim you make follow from the same paragraph.

What you get

A statement you can edit, the indications for use, and the points where your wording commits you to evidence. Narrow wording is cheaper to prove.

Private

It runs in your browser. Your answers live only in the address of this page, and move to the next tool only when you follow its link. Nothing is sent to us unless you choose to send it.

Other tools

Each one answers a different question in the same scoping conversation, and each runs in your browser.

Readiness checkEight questions on the need, the build and the market. You get a plain verdict on whether to build now, and the three steps that would move it most.
Class and routeFind the likely risk class of your device under the Medical Devices Rules, 2017, the licence and the form you apply on, the standards that apply and the route step by step.

Questions about the intended use builder

Are my answers sent to you?

No. The tool runs in your browser and does not send your answers to us. The site's analytics counts page visits, and whether a tool was started or finished, without cookies. It does not see what you enter.

Why does the intended use matter so much?

Under the Medical Devices Rules, 2017 the class follows the intended use you state. The tests, the clinical evidence, the label and every claim you make must match the same paragraph.

Is the statement ready to file?

It is a first draft in the right shape. Your regulatory file needs it checked against the evidence you will actually have, and Regulatory Affairs confirms it.

Why does it point out some of my words?

Words such as safe, painless or cure are claims, and each claim needs evidence. Narrow, plain wording is cheaper to prove.