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Medical Devices › Artificial Intelligence › United Kingdom

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Hogan Lovells

International AI Regulatory Contrast: Evolving frameworks in the EU, UK, and US

Hogan Lovells on

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have...more

Hogan Lovells

MHRA confirms five technologies selected for AI Airlock Pilot

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the five technologies selected to participate in the ‘AI Airlock Pilot’ for AI-powered medical devices. The pilot is a regulatory “sandbox” for...more

Hogan Lovells

JPM2025: AI integration into UK’s MHRA’s processes presents opportunities, and challenges for regulating medicinal product...

Hogan Lovells on

Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more

Hogan Lovells

UK MHRA Publishes AI Regulatory Strategy

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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)

Faegre Drinker Biddle & Reath LLP on

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 & Schulte

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Schulte 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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