Spotlight on... Women's health and innovation: Navigating Femtech regulatory compliance in the EU – A legal conversation
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Spotlight on... Women's health and innovation: Navigating Femtech regulatory compliance in the EU – A legal conversation
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概要
Those working in the Femtech space have a difficult regulatory framework to navigate in the EU. For products that qualify as a medical device, the EU Medical Device Regulation imposes onerous obligations. In addition, the AI Act, as it stands, add additional regulatory requirements for devices including AI.
In this podcast Xisca Borrás and Ellie Handy discuss when software will qualify as a medical device, the regulatory obligations for devices and the challenges Femtech manufacturers may face in complying with them. They then cover the interaction between the EU MDR and AI Act, discussing how to navigate them.
In view of the European Commission’s proposal to simplify the rules applicable to medical devices, issued after the recording of this podcast, the impact of the AI Act on medical devices may change significantly in the future, so stay tuned for more updates about the changing landscape that applies to AI.