Device Positioning Tool

Regulatory Strategy

Your insights may take 30 seconds to 1 minute to appear. No need to click refresh!

These questions may help you position your product within the medical device framework by helping you to formulate clear answers to the following questions: "What does my device do? Who is it for? How does it work?". Use the workflow below to think through your device. Enter detailed information to receive a draft Intended Use statement, potential regulatory positioning, and guidance on what you still need to clarify.

This tool does not replace a regulatory assessment, and may make mistakes. Its intention is to help you define your product positioning early in your product development journey, so that you can build the appropriate strategy.

Device
Function
Population
Users & Setting
Pathway
1
What is the device?
The device form factor anchors classification rules and which standards apply to your development program.
Single-use vs. reusable is a primary classification driver in most frameworks — it affects sterility requirements, labelling, and post-market surveillance obligations.
Single-use
Multi-patient reusable
Single-patient reusable
Software only
Whether a device is supplied sterile, requires sterilisation before use, or is non-sterile determines which manufacturing standards apply and can shift device class significantly.
Supplied sterile
Requires sterilisation before use
Non-sterile
Not applicable
2
What is the device designed to do?
The medical function is the single most consequential choice in your statement. It determines regulatory pathway, predicate strategy, and clinical evidence burden.
"Diagnose" carries a much higher evidence bar than "aid in the diagnosis of." Choose carefully.
Diagnose
Aid in diagnosis
Screen
Detect
Monitor
Predict
Treat
Manage
Alleviate symptoms of
Clinical decision support
Calculate risk of
This separates what is measured from why it is measured — a distinction regulators care deeply about. "Monitors HRV" is a mechanism; "to detect infection" is a clinical purpose, while "to help healthy users understand their cycle" is a wellness purpose. The answer here is one of the biggest drivers of whether your device needs regulatory clearance at all.
The operating principle explains how the device achieves its function — e.g. via algorithm, biosensor, electrical stimulation. Required for many regulatory submissions and risk management documentation.
Whether your output is a recommendation vs. a measurement fundamentally changes your evidence requirements.
Qualitative (yes/no)
Quantitative measurement
Risk score / probability
Treatment recommendation
Alert / notification
Trend / longitudinal data
3
Who is the device used on?
The patient population defines the scope of your clinical evidence. Regulators assume the broadest possible population if you don't specify one.
Be specific: age range, sex, disease stage, relevant comorbidities. Vague populations expand your evidence burden.
Explicitly stating who is excluded contains your evidence requirements and protects against off-label use claims.
4
Who operates it, and where?
The intended user and use environment drive usability requirements, labelling, and risk management scope.
Physicians
Trained clinical operators
Licensed HCPs
Lay users / patients
Caregivers
Clinicians & patients
Environments like home use or emergency settings trigger additional IEC 62366 usability requirements and risk considerations.
Hospital / clinic
Point of care
Operating room
ICU / critical care
Home use
Home & clinical
5
Where does it fit in the care pathway?
This is often the most overlooked element — and the one that most affects your regulatory risk tier and predicate strategy.
A standalone diagnostic tool faces a very different regulatory path than a tool that supplements a clinician's existing workflow.
Standalone / replaces existing method
Adjunct to clinician decision-making
Pre-diagnosis screening
Treatment planning / guidance
Post-diagnosis / post-treatment monitoring
Patient self-management
Please complete all required fields before generating.
Drafting your statement…