News & Analysis as of

Medical Devices Technology Sector European Union

A&O Shearman

AI in healthcare: Legal and ethical considerations in this new frontier

A&O Shearman on

Can human beings cure all diseases in our lifetime? For centuries, humanity has strived to cure diseases. With the advent of Artificial Intelligence (AI), the dream of a disease-free world seems more attainable than ever...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Goodwin

How the EU AI Act Could Affect Medtech Innovation

Goodwin on

The EU AI Act, which went into force on August 1, 2024, introduces specific rules for artificial intelligence (AI) systems, especially those deemed “high risk.” Medtech devices, products, and services — such as...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

McDermott Will & Schulte

Key Features of the New EU Product Liability Directive: Increased Potential for Litigation in the Technology, Pharmaceutical and...

McDermott Will & Schulte on

On October 10, 2024, the Council of the European Union adopted the new EU Directive on Liability for Defective Products (New PLD), repealing Directive 85/374/EEC (PLD), adopted in 1985....more

King & Spalding

EU Artificial Intelligence Regulation Published - What You Need to Know

King & Spalding on

Friday, July 12, 2024, the EU published the new EU Artificial Intelligence Regulation, which is first EU AI Regulation worldwide setting requirements concerning safety and free movement of goods and services using AI...more

Hogan Lovells

Implications of the EU AI Act on medtech companies

Hogan Lovells on

The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that AI systems in the EU are safe,...more

McDermott Will & Schulte

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Hogan Lovells

The EU regulatory challenges and liability risks associated with 3-D printed medical devices

Hogan Lovells on

In this hoganlovells.com Q&A, Hogan Lovells counsel Fabien Roy addresses EU regulations that apply to medical devices that are produced using 3-D printing technologies....more

Hogan Lovells

Regulate Frankenstein: the European Parliament calls for new rules for robots

Hogan Lovells on

When a parliamentary report cites Mary Shelley’s Frankenstein in its recitals and proposes new regulation for robots with artificial intelligence (“AI”), one cannot be sure whether the 19th or the 21st century has inspired...more

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