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United Kingdom Artificial Intelligence Medical Devices

Hogan Lovells

UK MHRA Publishes AI Regulatory Strategy

Hogan Lovells on

On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI White Paper, published in August 2023....more

Faegre Drinker Biddle & Reath LLP

AI Regulation in the U.K. — New Government Approach (Updated)

In October 2022, the U.K. Medicines and Health products Regulatory Agency (MHRA) published its Guidance, Software and AI as a Medical Device Change Programme – Roadmap, setting out how it will regulate software and AI medical...more

MoFo Life Sciences

FDA And International Counterparts Release Best Practices For Machine Learning In Medical Device Development

MoFo Life Sciences on

This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified 10 guiding principles to inform the development...more

McDermott Will & Emery

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Emery on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Hogan Lovells

International Products Law Review 2019: Issue 75

Hogan Lovells on

We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness of AI, a consumer whistleblowing...more

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