Intended Use
Summary
Intended use defines the specific purpose, medical indication, and application for which your medical device is designed and marketed. This foundational document establishes the scope of your device’s functionality and directly determines your regulatory classification, required testing, and submission pathway. Your intended use statement must be precise, defensible with data, and will appear in your instructions for use.
Why is Intended Use Important?
Intended use is the cornerstone of medical device regulation because it determines everything that follows in your certification process. Regulatory authorities use your intended use to classify your device, establish testing requirements, and evaluate safety and effectiveness. A well-defined intended use protects you from regulatory scope creep while ensuring you can defend every claim with appropriate evidence. Your intended use statement becomes legally binding and must be supported by your clinical evaluation, risk management, and verification testing.
Regulatory Context
Under 21 CFR 801.4 and 21 CFR 814.20(b)(3):
- Intended use determines device classification and regulatory pathway (510(k), PMA, De Novo)
- Must be clearly stated in labeling and instructions for use
- Drives predicate device selection for substantial equivalence claims
- Establishes scope for clinical data requirements and testing protocols
Special attention required for:
- Software medical devices - intended use affects algorithm validation requirements
- AI/ML devices - must specify learning capabilities and clinical decision support level
- Combination products - intended use must address each component’s function
- Novel devices - may require De Novo pathway if no appropriate predicate exists
Under 21 CFR 801.4 and 21 CFR 814.20(b)(3):
- Intended use determines device classification and regulatory pathway (510(k), PMA, De Novo)
- Must be clearly stated in labeling and instructions for use
- Drives predicate device selection for substantial equivalence claims
- Establishes scope for clinical data requirements and testing protocols
Special attention required for:
- Software medical devices - intended use affects algorithm validation requirements
- AI/ML devices - must specify learning capabilities and clinical decision support level
- Combination products - intended use must address each component’s function
- Novel devices - may require De Novo pathway if no appropriate predicate exists
Under EU MDR 2017/745:
- Article 2(12) defines intended purpose as the basis for classification under Annex VIII
- Must be documented in technical documentation (Annex II, Section 1.1)
- Drives conformity assessment procedure selection and notified body involvement
- Establishes scope for clinical evaluation under Article 61
Special attention required for:
- Software medical devices - MDCG 2019-11 guidance on qualification and classification
- AI systems - must specify autonomous vs. semi-autonomous decision-making
- Borderline products - MDCG 2022-5 guidance for medical device vs. non-medical device determination
- Class III devices - intended purpose must justify high-risk classification
Guide
Your intended use document must comprehensively define your device’s purpose and application. Start with your core functionality - what does your device actually do? Describe the medical condition or clinical need it addresses, but avoid overpromising capabilities you cannot defend with data.
Define your medical indication clearly. Specify the disease, condition, or physiological parameter your device monitors, diagnoses, treats, or prevents. Use established medical terminology and avoid vague language. Your indication must align with your clinical evaluation and any claims you make.
Identify your patient population precisely. Include relevant demographics, health conditions, and any exclusions. Consider age ranges, disease severity, comorbidities, and other factors that affect device use. Your patient population drives your clinical evaluation requirements and risk assessment.
Describe your user profile in detail. Specify who will operate your device - healthcare professionals, patients, or caregivers. Include required training, qualifications, or competencies. Your user profile affects your usability requirements and instructions for use.
Document your use environment comprehensively. Describe where and how your device will be used - hospital, clinic, home, ambulatory setting. Include environmental conditions, required infrastructure, and any supporting equipment or software. Your use environment affects your design requirements and risk assessment.
Explain your operating principle clearly. Describe how your device works at a high level without revealing proprietary details. Include input data, processing methods, and output information. Your operating principle must be consistent with your technical documentation and risk analysis.
Specify body interaction if applicable. If your device contacts the body, describe the anatomical location, tissue type, and nature of contact. This information drives your biocompatibility requirements and classification under MDR Annex VIII rules.
Address variants and accessories appropriately. Document any different configurations, optional features, or accessories that are part of your device system. Each variant may require separate consideration for classification and testing.
Example
Complete Intended Use Document
Intended Use
ID: IU-2024-001
Product
- Name: CardioWatch Pro
Intended Use / Intended Purpose
CardioWatch Pro is a wearable medical device intended for continuous monitoring and recording of heart rate and heart rhythm in adults (18 years and older) in home and clinical settings. The device provides real-time heart rate measurements and stores electrocardiogram (ECG) data for healthcare provider review to support clinical decision-making in patients with known or suspected cardiac arrhythmias.
Intended Medical Indication
Monitoring of heart rate and rhythm in adult patients with diagnosed or suspected cardiac arrhythmias, including atrial fibrillation, premature ventricular contractions, and bradycardia. The device is intended to detect and record irregular heart rhythms for healthcare provider evaluation and does not provide automated diagnosis or treatment recommendations.
Contraindications
- Patients under 18 years of age
- Patients with implanted cardiac devices (pacemakers, ICDs) without physician approval
- Patients with known allergies to device materials (silicone, stainless steel)
- Use during MRI procedures
- Use in patients requiring continuous cardiac monitoring in critical care settings
Patient Population
Adult patients (18 years and older) with known or suspected cardiac arrhythmias who require intermittent or continuous heart rhythm monitoring outside of hospital settings. This includes patients with atrial fibrillation, patients on antiarrhythmic medications, and patients experiencing symptoms suggestive of cardiac arrhythmias such as palpitations, dizziness, or syncope.
User Profile
Primary users are adult patients capable of operating a wearable device and following basic instructions. Secondary users are healthcare providers (physicians, nurses, cardiac technicians) who review recorded data and provide clinical interpretation. Patients must be able to charge the device, wear it properly, and use the companion mobile application for data synchronization.
Use Environment Including Software/Hardware
The device is intended for use in home, clinic, and ambulatory settings. The wearable sensor operates in normal indoor and outdoor environments (temperature range 10-40°C, humidity 15-85% non-condensing). The system requires a compatible smartphone (iOS 14+ or Android 10+) with Bluetooth connectivity for data transmission and a secure cloud platform for data storage and healthcare provider access.
Operating Principle
CardioWatch Pro uses a single-lead ECG sensor with dry electrodes to detect electrical activity of the heart. The device continuously samples cardiac signals at 250 Hz, applies digital filtering to remove artifacts, and calculates heart rate using R-wave detection algorithms. ECG waveforms are stored locally and transmitted via Bluetooth to a mobile application, which uploads data to a secure cloud platform for healthcare provider review through a web-based dashboard.
Part of the Body / Type of Tissue Interacted With
The device contacts intact skin on the chest area through dry metal electrodes (stainless steel). Contact is non-invasive and limited to the external surface of the skin. The device does not penetrate the skin or contact internal body structures.
Variants / Accessories
CardioWatch Pro is available in three sizes (Small, Medium, Large) to accommodate different chest circumferences. The system includes a charging dock, mobile application (iOS/Android), and web-based healthcare provider dashboard. No additional accessories are required for normal operation.