In her latest blog, Hanover Brussels, Aleksandra Lugovic explores concerns over the growing coexistence of health applications and electronic products that may become medical devices under EU regulation.
Pending more concise guidance from the European Commission, it is left to our own interpretation how far the Medical Device Regulation (MDR) will go when it comes to classifying consumer electronic devices as medical devices.
The interplay between general consumer goods and medical software has been a revolutionary development for public health, given the large number of medical applications that monitor the health of the general public through a range of electronic devices. However, many manufacturers of consumer goods, not intended for medical purposes, are increasingly concerned that these devices will be classified as medical, simply because they allow and facilitate the work of third-party health applications.
The classification of common hardware sensors (microphone, camera, etc.) as medical device accessories is a worrying prospect because it means that any phone, tablet or watch could be considered a medical device accessory if it facilitates the work of a health application, such as sleep monitoring, heart rate meter or other available applications. This would ultimately mean that these devices would have to undergo the same regulatory review and costly approval as devices for medical use, such as an ECG machine.
Under the MDR which began in May this year, a medical device accessory must go through the same regulatory process as medical devices, which comes with significant and costly compliance obligations to stay or enter the market. the EU. 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 coming years. to come. As consumer goods such as cars, computers and printers increasingly make their hardware available to external applications, this could mean that our home appliances could also be classified as medical devices.
The solution is simple. Rather than imposing additional burdens on manufacturers and regulators while they are still recovering from a pandemic, the European Commission should stick to the MDR base. All devices must be used for their intended purpose, which means that devices intended to provide medical or health assistance to the public, including applications, must indeed be classified as medical devices under the MDR. However, devices whose original purpose is not linked to health or medical assistance must remain general consumer goods as they have been for many years.