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Will most electronic consumer goods turn into medical devices after the MDR?

In her latest blog, Hanover Brussels Aleksandra Lugovic explores concerns over the rising coexistence of health apps and electronic goods that may become medical devices according to the EU Regulation.

Whilst waiting for more concise guidance from the European Commission, it is left to our own interpretation as to how far the Medical Device Regulation (MDR) will go when it comes to classifying general consumer electronics as medical devices.  

The interaction between general consumer goods and medical software has been a revolutionary development for public health, given the vast number of medical applications that monitor the general public's health across a range of electronics. However, there is a rising concern among many manufacturers of consumer goods, not intended for medical purposes, that these devices could become classified as medical, simply because they allow and facilitate the work of third-party health apps.

The classification of common hardware sensors (microphone, camera, etc.) as medical device accessories, is a worrying prospect as it means that any phone, tablet, or watch could be considered a medical device accessory if facilitating the work of a health app, such as sleep monitoring, heart rate reader or other such available apps. This would eventually mean that these devices would have to undergo the same regulatory scrutiny and costly approval as devices with intended medical purposes, such as an ECG machine.

Under the MDR that kicked-off in May this year, a medical device accessory is required to undergo the same regulatory process as medical devices, which comes with considerable and costly compliance obligations to remain or enter the EU market. If this is to eventually include everyday electronics, we are likely to face a significant reduction in product diversity and innovation in the EU, as well as substantial price increases in the years to come. As consumer goods such as cars, computers and printers are increasingly making their hardware available to external apps, this could mean that our household devices could also become classified as medical devices.

The solution is simple. Rather than imposing further burdens to manufacturers and regulators when they are still recovering from a pandemic, the European Commission should stick to the basis of the MDR. All devices should be used for their intended purpose, meaning that devices with the intention to provide medical or health support to the public, including apps, should indeed be classified as medical devices under the MDR. However, devices with an original purpose not related to health or medical assistance should remain general consumer goods as they have been for many years.

20th September 2021

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