In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has published guidelines making it clear that, "the manufacturer of a device is responsible for establishing that the device is safe and that it is suitable for its intended purpose. To establish this, manufacturers must implement appropriate controls on the device design and manufacture, and evaluate the safety and performance of the device in its intended application".
It is clear that the world of wearable devices is not all that it seems at first glance. On a deeper exploration it is evident that there are numerous economic, cultural and regulatory changes needed before a sustainable and safe integration of wearable medical devices into our everyday lives. With the right power management, design and production controls and when used under the guidance and on the recommendation of a healthcare professional, wearable devices can become a viable asset in improving the health of our increasingly ageing population.
About the Author
Neil Oliver is technical marketing manager at Accutronics Ltd - www.accutronics.co.uk.