Wearables have long been an integral part of everyday life. Whether fitness trackers, smartwatches or smart rings — they provide data on sleep, heart rate, stress or activity and promise to better understand your own health. But with the growing number of ever more complex functions, the line between harmless ones is blurring wellness tools and genuine medical devices.

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A recent case in the USA shows how sensitive this issue is. How The Verge reported, the manufacturer Whoop was officially warned by the US health authority FDA (Food and Drug Administration). Reason: A new feature that estimates blood pressure based on sleep and activity data — without the necessary medical approval.

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Wellness or diagnosis — where is the limit?

The term wellness is not just a marketing buzzword. For manufacturers, it means a clear regulatory distinction: As long as a product is only intended to “promote well-being” and does not make a medical diagnosis, the legal requirements are significantly lower.

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Examples of pure wellness features:

• Step counting or calorie consumption
• Stress level or sleep phase indicators
• Breathing exercises or meditation programs

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It becomes critical when a device provides measurement values that allow medical conclusions — such as high blood pressure, heart rhythm disorders or incipient illnesses. In this case, the product is considered a medical device and is subject to significantly stricter rules.

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The Whoop case: blood pressure without a measuring cuff

Whoop has developed a feature that estimates blood pressure based on various vital signs such as heart rate, heart rate variability, and sleep patterns. The FDA found this to be problematic, as users could easily interpret such data as medically reliable — even if it “only” represents an estimate.

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Risk:
Repeatedly displayed “high blood pressure levels” could encourage people to make medical decisions on their own — such as stopping medication or requesting additional tests — without a doctor's diagnosis.

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Whoop argues that it is a wellness feature that simply shows trends. The FDA sees things differently and requires a clear distinction and approval as a medical device before the function can be further advertised.

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Other manufacturers in the grey area

Whoop is not an isolated case. More and more providers are operating in a regulatory grey area to bring innovations to market quickly:

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• Oura Ring:
  With a “symptom radar”, indicates when a cold could be on the way — officially not a diagnosis, but a clear health reference.

• ‍Apple Watch:
  In the EU, the ECG feature is approved as a medical device. Other functions such as blood oxygen measurement, on the other hand, are declared as wellness tools.

• Samsung Health Monitor:
  It already offers blood pressure measurement in some countries, not yet in others — subject to local approval.

• ‍Blood sugar monitoring:
  The first wearables are working on continuous glucose measurement, but often present the data as “wellness scores” in order to avoid legal requirements.

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EU regulations: Stricter but more complex

While new functions are often tested quickly in the USA and only regulated retrospectively, there is a different approach in the EU — this is where the Medical Device Regulation (MDR) whether a device is classified as a medical device. It has been in force since May 2021 and is one of the strictest regulations worldwide.

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Key points of MDR:

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• Medical purpose:
  If a device is intended to diagnose, prevent, or treat diseases, it automatically falls under MDR.

• Approval requirement:
  CE marking is required before market launch — including clinical data and safety evidence. The CE mark shows that a product meets all EU requirements for safety and quality.

• ‍Data protection:
  Many wearables have Bluetooth and authentication vulnerabilities. From 2027, the Cyber Resilience Act comes into action, which introduces mandatory cybersecurity standards.

• Clear language:
  Terms such as “heals”, “treats” or “diagnoses” are taboo if the product is not certified accordingly.

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Examples:

A fitness tracker that only counts steps is not a medical device. A smartwatch ECG with warnings of cardiac arrhythmias is becoming a class IIa medical device.

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Benefits and challenges of EU rules

Stricter regulation in the EU protects consumers better, but also poses challenges.

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Advantages:

• Clearly defined legal responsibility
• Protection against misleading advertising
• Uniform safety standards

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Challenges:

• Complex and cost-intensive certification processes
• Differences in implementation between EU countries
• Delay in bringing innovations to market

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Why the topic is so important

Wearables are becoming ever more sophisticated and are increasingly penetrating areas that were previously reserved for doctors. For consumers, this means:

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Opportunities:

• Early warning signs of health problems
• Personalized insights into your own body
• Motivation for healthier lifestyle habits

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Risks:

• Incorrect security due to inaccurate or unvalidated data
• Self-diagnoses without medical supervision or support
• Misinterpretations which, in the worst case, can lead to health damage

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Conclusion: Clear communication is crucial

The Whoop case shows how difficult it is to differentiate between wellness and medical devices. While manufacturers in the USA initially operate freely and are only regulated later, the EU is relying on strict requirements from the moment they enter the market. It is becoming increasingly important for companies to communicate transparently which functions are purely informative — and which are actually diagnostic in nature.

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The following applies to users: Wearables are valuable companions for health monitoring and prevention. However, the data should always be seen in context — and medical advice remains essential.