Is Your Digital Health Product a Medical Device?

The digital health revolution is in full swing. The XXI century is catching up with patients’ needs and demands. 

One analysis puts the global digital health market at $377 billion in 2024, and another estimates $947 billion by 2030. There is no denying that digital health is changing prevention and care, with plenty of new products entering the market. But there’s a crucial question that creators of digital health products have to answer:

When does a digital health product become a medical device? 

The answer determines everything from development costs to regulatory timelines, and recent changes make this classification more important than ever.

Types of Digital Health Products

• Wearables represent the most visible type, ranging from basic fitness trackers like Fitbit devices focused on step counting and general wellness to regulatory-approved medical-grade monitors. 

• Mobile health applications encompass wellness apps (e.g. Headspace) that avoid medical claims, patient engagement platforms for appointment scheduling and communication, and prescription digital therapeutics like (e.g. RESET for substance use disorder) that require full FDA approval with clinical trial evidence. 

• Telemedicine platforms include basic video communication tools that facilitate remote consultations, AI-powered diagnostic software requiring medical device clearance, or clinical decision support systems that analyze patient data for diagnostic recommendations.

• Remote monitoring devices include both consumer wellness trackers and medical-grade systems. Solutions like continuous glucose monitors (e.g. Dexcom) require regulatory approval, while general activity monitors remain consumer products. The key difference is whether the device provides clinical-grade data for medical decision-making or general wellness insights for personal use.

• AI diagnostic tools represent the fastest-growing regulated category. These range from medical imaging AI systems analyzing mammograms and chest X-rays to clinical decision support tools providing treatment recommendations. The majority focus on radiology applications, though expansion into pathology, cardiology, and primary care continues accelerating.

Digital health solutions use technology to help improve people’s health and wellness. However, since it’s a very broad and rapidly growing sector, it’s not that simple.

Digital health encompasses a vast spectrum of solutions. On one end, you have fitness trackers and wellness apps that help you maintain a healthy lifestyle. On the other, there are AI-powered diagnostic tools, digital therapeutics, and devices like bracelets that alarm emergency services when you have a heart attack. Not to mention robots like the da Vinci Surgical System.

Consider the range: a smartwatch that tracks your steps operates very differently from software that analyzes medical images for cancer detection. Both use technology to improve health outcomes, but only one requires FDA approval as a medical device.

The line isn't always clear. Certain features on the Apple Watch and the Samsung Galaxy Watch received FDA clearance that made them medical diagnostic tools. This trend of consumer products gaining medical capabilities is reshaping how we think about device classification.

What Makes a Medical Device?

Whether a digital health solution can be referred to as "medical" depends on legal circumstances – and you have to adjust to the regulations of each jurisdiction you enter. 

Legal definitions remain consistent globally, but enforcement has evolved. Long story short: medical device classification depends on intended use and risk assessment.

The EU defines a medical device as any instrument, apparatus, software, or material "intended by the manufacturer to be used for human beings" for purposes including "diagnosis, prevention, monitoring, treatment or alleviation of disease." The U.S. FDA uses similar language under the Federal Food, Drug, and Cosmetic Act.

The key word is "intended." Regulators look at how you market, label, and distribute your product to determine intended use. A heart rate monitor positioned for fitness has different regulatory requirements than one marketed for detecting arrhythmias.

Recent enforcement actions, like the 2024 WHOOP warning letter over blood pressure monitoring, show regulators are scrutinizing these boundaries more carefully. The FDA stated that blood pressure monitoring is "inherently associated" with medical diagnosis, regardless of wellness disclaimers.

In the United States, FDA's three-tier classification system determines regulatory requirements based on risk and intended use. Class I devices like basic electronic thermometers require minimal oversight through general controls. Class II devices like most digital health applications need 510(k) clearance demonstrating substantial equivalence to existing products. Class III devices for life-critical applications require full premarket approval with comprehensive clinical trials.

The "intended use doctrine" serves as the primary determinant. This means the manufacturers' stated objectives for product use as reflected in labeling, marketing, and instructions. Products making diagnostic claims, providing treatment recommendations, or supporting clinical decision-making typically qualify as medical devices regardless of underlying technology.

In the European Union, Medical Device Regulation uses a four-class system (I, IIa, IIb, III) with Rule 11 specifically addressing software. Most digital health software defaults to Class IIa or higher, requiring notified body involvement and CE marking. Only limited categories like basic medical calculators qualify as Class I with self-certification options.

Software as Medical Device (SaMD) frameworks adopted internationally classify products across risk categories based on healthcare situation criticality and information significance (treat/diagnose, drive clinical management, inform clinical management). For a detailed overview of SaMD standards worldwide, read: “What are the Global SaMD Standards: Regulations for Medical Software.”

Key Differences: Medical Devices vs Consumer Products

The fundamental distinction comes down to risk and medical purpose. 

• Medical devices focus on specific medical problems, like detecting diseases, guiding treatment decisions, or delivering therapy. 

• Health and wellness apps typically promote general fitness and lifestyle improvements.

Developing medical devices requires significantly more investment. You need clinical trials, regulatory submissions, quality management systems, and ongoing compliance monitoring. The process is complex but validates your product's safety and effectiveness.

Non-medical health and wellness products can launch faster and cheaper, but face limitations in the claims they can make. Consumer products must avoid specific medical claims and instead use carefully crafted language like "may help reduce risk of" accepted chronic conditions or "supports general wellness." Companies cannot reference diagnosis, treatment, cure, or prevention of diseases beyond limited exceptions.

Design limitations for consumer products include prohibitions on providing real-time medical alerts, specific medical recommendations, or clinical decision support. Products must present information for user interpretation rather than directing medical interventions.

Why Pursue Medical Device Classification?

Our clients that have chosen the medical device path have consistently reported these benefits:

• Differentiation - the wearables market is crowded. Many devices simply don't operate properly. "But our device works, believe us!" is very risky.

• Proven effectiveness - obtaining medical certification requires conducting clinical trials. It allows you to evaluate your device's performance. It's time-consuming, but in many cases, it's truly effective and helps you improve.

• Professional credibility - medical devices with proven effectiveness are more reliable and professional than non-certified products.

• Higher price - which means a higher margin.

Despite the complexity, medical device status offers compelling advantages. The market is less crowded with "me-too" products that don't actually work. Medical certification through clinical trials demonstrates real effectiveness, not just marketing promises.

From a business perspective, medical devices command higher prices and better reimbursement potential. Healthcare systems and providers take regulated products more seriously than wellness apps. The credibility and trust that comes with FDA clearance or CE marking opens doors that remain closed to unregulated products.

Should You Build a Medical Device?

Both certified medical devices and consumer products can positively impact people’s lives. Success isn't determined by regulatory status alone, but by solving real problems effectively.

The choice between medical device and consumer product development depends on your product's intended use, target market, and business model. Medical devices offer credibility and reimbursement potential but require significant investment in clinical validation and regulatory compliance.

The key question remains: does your product diagnose, treat, or directly influence medical decisions? If yes, you're likely looking at medical device requirements. If your focus is general wellness and lifestyle improvement, you may have more flexibility. And if you’re at a crossroads and not sure what to decide, reach out to us and we’ll help.