Most health numbers on a consumer smartwatch are wellness estimates, not medical measurements. A handful of specific features, such as some ECG apps and blood-pressure functions, have been reviewed by a regulator for a narrow purpose; the rest have not. A spec sheet that lists "blood pressure" or "SpO2" does not tell you which kind you are getting. Nothing here is medical advice.
Wellness feature or medical device?
Regulators draw the line by intended use. In the United States, the FDA's general wellness policy, updated in January 2026, says products that use non-invasive sensing to estimate values such as blood pressure, oxygen saturation, blood glucose or heart rate variability can be treated as low-risk wellness products, which the FDA does not intend to examine. That applies only if they are meant for wellness, are not intended to diagnose or treat a disease, do not substitute for an authorised medical device, do not prompt specific clinical action, and any values that mimic clinical ones are validated. Products intended for screening, diagnosis, monitoring or management of a disease, such as blood-pressure monitors and ECG analysis devices, are medical devices.
In the European Union, medical device rules apply to software that has a medical purpose. EU guidance says a maker's medical claims must be supported by clinical evidence; otherwise the software may not be CE marked as a medical device or make those claims. Bear in mind that a CE logo on a watch box can simply reflect the EU rules for electrical and electronic equipment; on its own it does not mean a health feature is a certified medical device.
In Egypt, medical devices are registered with the Egyptian Drug Authority (EDA). We found no EDA statement about smartwatch health features, so this guide makes no claim about which watch features are registered in Egypt and uses the US and EU rules only to explain the difference.
The same watch often mixes both kinds. Huawei says the blood-pressure functions and the ECG app on its WATCH D2 are CE certified under the EU Medical Device Regulation, while its heart rate, SpO2, skin temperature and sleep breathing features are not intended for medical use. Apple describes its Blood Oxygen app as for wellness purposes only and not for medical use, while its ECG app was granted marketing authorisation by the FDA through the De Novo route in 2018.