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Regulatory Affairs, Medical Devices

Comparing EU and FDA approaches to regulating MedTech software and AI - WHITEPAPER


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Recent changes to the regulatory landscape of medical technology software across regions, with respect to the classification and approval process of medical devices, is having significant impacts on the medical device industry.

While the FDA approval process requires that the device be proved efficacious in comparison to a control device or be substantially equivalent to a predicate device, the EU approval process is based on the intended function of a medical device. Several recent high-profile device failures have resulted in the regulators in both regions calling for stringent controls over the approval process of medical devices.

This whitepaper explores the changes and differences across the regulatory landscape in different regions, including:

  • Overview of key changes across the international regulatory landscape for medical device software

  • Understanding the different requirements for standalone and integrated software

  • Software apps and wearables: clarifying when a clinical investigation should be carried out to gain a CE-mark and/or FDA approval

  • Exploring go-to-market strategies across Europe and US

  • Assessing time and resources required to ensure sufficient clinical evidence is gathered

  • Timelines for approval

  • Progress on regulating AI and machine learning

  • Update on the FDA whitepaper and EU commission papers on regulating AI

  • Identifying European and Chinese intentions to regulate AI

  • Overview of standardization initiatives related to AI

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