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June 22, 2016

Am I wearing a medical device?

Working in Factory CRO’s clinical operations team, it’s all about collecting data and setting up clinical trials. As a movement scientist I was used to collect my own personal data during my training in university, but the new Garmin watch I got as a birthday present brings all to a new level. I suddenly became aware of the possibilities of the current data tracking devices when I woke up and received a Garmin alert suggesting I had problems finding a good sleep pattern. Most likely this alert had something to do with the lack of sleep because of the party for the same birthday a couple of days earlier.

Remember our work is about medical devices and we are familiar with the definitions of medical devices and the demarcation criteria. When one looks at the definition of a medical device one should pay attention to the part ‘intended by the manufacturer to be used specifically for diagnostic and/or therapeutic purposes’. If a manufacturer claims the intended use of his device is to collect, detect, measure or analyze data, he can stay away from the conformity assessment procedures to the essential requirements for medical devices as defined in Annex I of MDD 93/42/EEC. But keep in mind; it’s a medical device if there’s a diagnostic or therapeutic claim. If manufacturers claim their device can be used to diagnose obesity, it no longer remains a wellness device and no longer remains unregulated by the MDD.

Manufacturers of running watches should not only pay attention to the demarcation criteria but should also adhere to the data processing provisions in the data protection directive transposed into national law. Please note Factory CRO has previously posted about the focus of the Dutch Data Protection Authority on personal data, big data and personal health data in 2016. A report from the Dutch Data Protection Authority following an investigation into Nike’s fitness app was referenced.

There is a lot of movement on the wearables market. The FDA has published a draft guidance document to help those creating wellness devices and apps. The goal is to encourage the development of devices that enhance a healthy lifestyle. The FDA also included examples of claims that general wellness device makers should not use if they are aiming to remain unregulated.

Thinking this over the Garmin watch is not considered a medical device as long as Garmin stays away from a diagnostic or therapeutic claim. This can only be assured as long as the data is not intended to be shared with e.g. healthcare providers. We currently see several manufactures debating on how far they can stretch the claim of their wearables aiming to remain unregulated and we even see the first companies jump the hoop and try to brand their wearables as medical devices.

Recommendation: The development of wellness devices and apps provide a new world of data collection that enhance a healthy lifestyle. I therefore believe that manufacturers should be encouraged to continue development of their device, without being limited by poor understanding of the national regulations. An FDA approach may also help manufactures in Europe defining the claims of their device.

By Niels van Tienen

About the author


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