Device Positioning Tool

Regulatory Strategy

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These questions can 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, possible 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
1
What is the device?
The physical form and software architecture are two consequential classification inputs.
How the device contacts or interacts with the body is a primary classification driver in most frameworks. Duration and nature of body contact is a determinant of risk tier.
No physical hardware
Continuously worn / wearable
Handheld / intermittently applied
Implantable
Drug delivery
Combination product
Please answer all questions above before continuing.
2
What is the device designed to do?
How you describe what your device does is the single most consequential positioning decision you will make. It determines whether you are a medical device at all — and if so, at what regulatory risk tier.
While EU MDR, UK MDR, and FDA definitions differ in some details, a product is generally a medical device if it is intended to: diagnose, prevent, monitor, predict, treat, or alleviate a disease or condition; compensate for an injury or disability; or investigate, replace, or modify the anatomy or a physiological process. If your product does any of these things, even partially, it is likely regulated as a medical device in at least one jurisdiction.
Yes
No — it is a wellness or lifestyle product
Please answer all questions above before continuing.
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.
Whether a clinician or a lay user operates the device is a primary driver of usability requirements. A device used without clinical supervision carries a higher burden to be safe and understandable in untrained hands.
Healthcare professional
Patient / lay user
Both
Home and community use introduces variables that clinical settings do not — power reliability, user distraction, absence of backup — and triggers additional usability and risk management requirements under IEC 62366 and most regulatory frameworks.
Clinical setting
Home / community
Both
Please complete all required fields before generating.
Drafting your statement…
Know before you build

Common questions about medical device classification

Regulatory classification shapes everything: your evidence requirements, your development timeline, and your route to market. These answers cover the questions founders ask most often.

A product is generally regulated as a medical device if it is intended to diagnose, prevent, monitor, predict, treat, or alleviate a disease or condition, or to investigate, replace, or modify anatomy or a physiological process. Crucially, it is the claim that triggers regulation, not the technology. Consider two wearable devices with sensors that can measure blood pressure: one that tracks "stress and wellness trends" sits outside the medical device framework; one that claims to measure and detect hypertension almost certainly falls within it.
Most frameworks use a risk-based classification system. Class I covers low-risk devices with minimal contact or consequence, such as a nipple shield. Class II covers moderate-risk devices, such as a menstrual cup. Class III is reserved for the highest-risk devices, typically those that sustain or support life or are implanted long-term. The higher the class, the more rigorous the clinical evidence and regulatory scrutiny required before you can market your device.
The frameworks share the same underlying principle, risk-based tiers, but apply it differently in practice. The EU MDR and UK MDR classify devices using explicit rules tied to factors like invasiveness, duration of body contact, whether the device delivers energy to the body, and whether it is used in a life-threatening condition. The FDA uses a product-code system with thousands of device types, each assigned a class and a corresponding regulatory pathway (510(k), De Novo, or PMA). A device that is Class II under FDA may be Class IIb under EU MDR. Global market strategies need to account for these differences from day one.
SaMD refers to software that is itself a medical device, not software that runs inside a hardware device, but software whose primary function is to diagnose, monitor, or treat. A standalone app that analyses ECG data to flag arrhythmia is a SaMD. A dosage calculator that gives clinical decision support may be one too, depending on how it is described and how much it influences clinical decisions. SaMD is one of the most actively evolving areas of medical device regulation, with specific guidance from FDA, IMDRF, and the EU.
Not necessarily. It depends on the device class and whether a predicate device exists. Most Class II devices in the US require a 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate. Class I devices are often exempt from premarket notification. Novel devices with no predicate may go through the De Novo pathway. Class III devices require a full Premarket Approval (PMA). Choosing the right pathway starts with understanding your device's classification and the regulatory history of similar products.
An Intended Use statement is a formal description of what your device is designed to do, for whom, and under what conditions. It is the regulatory anchor for your entire development programme. It determines your device class, your clinical evidence requirements, your labelling, and your post-market obligations. Getting it right early prevents costly repositioning later. Many founders write it too broadly, increasing evidence burden, or too narrowly, limiting their addressable market.
The typical journey involves: confirming whether your product is a medical device, determining its classification under your target markets' frameworks, identifying the applicable regulatory pathway and submission type, building a Quality Management System (typically to ISO 13485), generating the required clinical and technical evidence, and making the relevant submission or registration. The timeline and cost vary enormously by class and market. A Class I EU MDR device may take 6 to 12 months; a Class III PMA submission can take 3 to 7 years.
It can. AI/ML-based software, particularly where the model's outputs directly influence clinical decisions, tends to attract higher scrutiny and may push a device into a higher risk class. The FDA's AI/ML action plan and more recent draft guidance treat AI-enabled devices as a distinct category requiring additional transparency and evidence. The EU AI Act creates parallel obligations for AI medical devices, though a December 2025 Commission proposal would absorb these into MDR entirely. If your device uses AI, declare it early and plan for additional evidence requirements.