Set to come into force this May, the updated EU Medical Device Regulation (MDR) will see manufacturers of medical devices and healthcare equipment, adhering to more stringent standards throughout a product’s lifecycle.
The aim is to improve patient safety across one of the world’s largest markets for medical devices, which accounts for an approximate €110 billion in annual sales.
Particular attention has been paid to IoT medical equipment and products that have programmable electronic software. Devices destined for the European marketplace will now have to undergo approval through a risk classification system that puts onus of cybersecurity predominately on the manufacturer.
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