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CE-approval on apps?

The Swedish Medical Products Agency has recently informed that it will be able to remove mobile health apps from the market.

In recent years the number of apps checking your health status available on phones and tablets has radically increased. Today you may use an app for a number of health issues; you may check your blood pressure, your hearing, your glucose levels or even use an app as a form of birth control. Hence, the value of the app market is growing year by year. According to the newspaper Computer Sweden, the health and fitness app market was valued at SEK 90 billion last year. It is expected to grow by 30 percent over the next five years.

But can you trust an app with your health? The Swedish Medical Products Agency has investigated this further and is currently reviewing a number of dubious health and fitness applications that could be potentially harmful. They have also started to warn the general public not to put too much trust into commercial apps and, starting this fall, they may market prohibit a health app.

When is an app a medtech product?

According to the Agency, the app in focus here is an app that diagnoses a patient’s health condition. This means that the app is a medtech product, which has to be CE-marked according to EU legislation. It is not CE-marked, so it should therefore be market prohibited. At the moment, only a few of the health apps available today have been certified by a regulatory agency, and some could even be potentially harmful, according to the Agency. They are therefore going through a number of apps that operate in a legal grey area. There is, according to the Agency, a big risk that the app gets something wrong and gives the user a false diagnosis, leading to the wrong treatment. In an interview with Computer Sweden, Mats Artursson, investigator at the Swedish Medical Products Agency mentions an example; an app that checks malignant melanoma, a diagnosis for which CE-marking is required.

“The app maker attempts to denounce responsibility by telling the user to contact a medical doctor in order to be sure. This is not okay according to the regulations,” said Artursson to the magazine. He and his colleagues now hope that these investigations will be a wakeup call for other health app manufacturers.