In the medical device regulatory ecosystem, “Intended Use”—also referred to as Intended Purpose in the EU MDR—forms the cornerstone of how a device is understood, classified, and evaluated by regulators. Across global frameworks, the concept remains consistent:
- FDA (21 CFR 801 & 21 CFR 860) defines intended use as the general purpose of the device or its function, including the medical conditions it is meant to diagnose, treat, cure, mitigate, or prevent.
- EU MDR (Regulation (EU) 2017/745) describes intended purpose as the use for which a device is intended according to the manufacturer’s instructions, labeling, and promotional materials.
- CDSCO (India's Medical Device Rules, 2017) follows the same foundation, requiring manufacturers to state the specific purpose, clinical benefits, and conditions of use in labeling and regulatory submissions.
Although wording varies slightly, the core requirement is universal: the manufacturer must clearly define what the device is meant to do, for whom, and under what conditions.
A precisely written Intended Use is not just a technical detail—it is the central element that determines the entire regulatory strategy of a medical device. It directly influences:
- Device classification and risk categorization
- Regulatory pathway and submission requirements (510(k), PMA, EU MDR CE marking, CDSCO Form MD-14/MD-22, MD-07/03 etc.)
- Risk management under ISO 14971
- Labeling, Instructions for Use (IFU), and promotional claims
- Clinical evaluation and clinical evidence requirements
- Performance testing and safety validation
- Software validation and SaMD categorization
- Post-market surveillance and vigilance obligations
Because of this, every aspect of a device’s safety, performance, and compliance ultimately traces back to a clear and consistent Intended Use statement. A poorly worded or overly broad intended use can lead to regulatory rejection, additional testing, misclassification, or even safety risks. In contrast, a well-defined intended use aligns the device’s design, evidence, labeling, and market positioning into one cohesive and compliant framework.
Understanding Intended Use & Indications for Use
Intended Use is the purpose of your device — what you claim on the label that the device does. It is not what the device could do or what the engineers designed it to do. It is only what your authorized labeling says the device does.
In regulatory systems like the FDA, EU MDR, and CDSCO, Intended Use directly affects:
- Device classification
- Risk assessment & control measures
- Labeling and claims
- Clinical evaluation & performance testing
- Software validation (if applicable)
- Market authorization pathway
“The device is intended to measure blood oxygen saturation (SpO₂) and pulse rate in adult and pediatric patients.”
Indications for Use describe the conditions, populations, and scenarios in which the device is used. This explains where, when, and how the device will be used — from a clinical standpoint.
Indications for Use usually answer:
- What illness, injury, or condition does the device manage, prevent, diagnose, or treat?
- Under what circumstances is the device used?
- Who is the target population?
- What anatomical site is involved?
- How long is the device used?
“The device is indicated for spot-check monitoring of SpO₂ and pulse rate in adult and pediatric patients in hospitals, clinics, and home-care environments.”
Here is the distinction in the simplest form:
- Intended Use = What the device does.
- Indications for Use = When, where, and for whom it is used.
Intended Use: “A dental scanner intended to capture 3D images of teeth.”
Indications for Use: “Indicated for use in adults for capturing impressions during orthodontic treatment planning.”
A clear distinction ensures proper classification, risk evaluation, and compliance in all major regulatory regions.
This concise section explains what a device is meant to do in clear clinical terms. Hover or focus any element below to see a short, contextual explanation on the right panel.
