The effect of COVID-19 on the new medical device regulation

The COVID-19 also affected the regulatory system of medical devices. In fact, in the face of the health emergency, the European Commission has presented a legislative proposal to postpone for one year the date of application of the new regulation on medical devices.

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Control phones and computers with your thoughts: Elon Musk’s latest challenge

Source: Neuralink

Elon Musk’s Neuralink, the secretive company developing brain-machine interfaces, showed off some of the technology it has been developing to the public for the first time. The goal is to eventually begin implanting devices in paralyzed humans, allowing them to control phones or computers. Continue reading

Why the medical software certification will revolutionise the market in EU

As foreseen by the new Medical Devices European Rules (UE 2017/45), to be operational from 26 May 2020, and by the Court of Justice sentence of 7 December 2017, medical software shall be certified as medical devices (MD) class IIA (with the exception of software aimed to archive, store and transmit data without any data elaboration and added value). This will have a great impact on the market. Continue reading