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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

White & Case LLP on

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

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Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

Morris James LLP on

Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

Bergeson & Campbell, P.C.

EC Announces Low- and High-Risk Countries under the EUDR

Bergeson & Campbell, P.C. on

The European Commission (EC) released on May 22, 2025, the identity of the countries that present a low or high risk of deforestation in producing seven commodities (cattle, cocoa, coffee, palm oil, rubber, soy, and wood)...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

Mitratech Holdings, Inc on

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Amundsen Davis LLC

Minimizing Product Liability Risks Caused by AI: Practical Tips for Businesses

Amundsen Davis LLC on

The use of artificial intelligence AI (AI) touches many sectors in the United States, and the business world is no exception. While this exciting development has proven useful for many businesses, it is also a new source of...more

Hogan Lovells

How to leverage Advanced Purchase Agreements for military supply

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The EU is introducing new regulations (EDIRPA and EDIP) to structure military procurement through pooled orders coordinated by the European Commission. Advanced Purchase Agreements (APAs), inspired by COVID-19 contracts,...more

Goodwin

EU Updates its Product Liability Regime: Important Considerations for Providers of AI Systems and Software

Goodwin on

The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more

Hogan Lovells

Key Implications for Consumer Hardware Manufacturers

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On 28 June 2025, the key requirements of Directive (EU) 2019/882 – also known as the European Accessibility Act or “EAA” – will take effect. The EAA is expected to lift barriers to accessibility across the EU, in turn...more

Alston & Bird

D-Day for the EU Cyber Resilience Act

Alston & Bird on

Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

Goodwin

The NIS 2 Era Is Here: Are You Compliance-Ready?

Goodwin on

With the deadline for Member States to transpose the European Union’s updated Network and Information Systems Directive (Directive (EU) 2022/2555) (NIS 2 or Directive) into national law, with the Directive having passed on 18...more

Dorsey & Whitney LLP

AI regulation introduced in Europe - setting the way forward for the rest of the world or slowing down the adoption of new tech?

Dorsey & Whitney LLP on

The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...more

Baker Donelson

Who's Who under the EU AI Act: Spotlight on Key Actors

Baker Donelson on

Who will play the leading role if we make a new series about AI? If you interview Steven Spielberg, Sundar Pichai, and Sam Altman, you might receive three distinct ideas ranging from the 2001 classic "AI: Artificial...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

K&L Gates LLP on

Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

Skadden, Arps, Slate, Meagher & Flom LLP on

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Foley & Lardner LLP

What Every Multinational Company Should Know About . . . Supply Chain Integrity

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Both enforcement agencies and consumers increasingly are focused on manufacturers’ supply chains. Human rights enforcement frameworks increasingly have real teeth. Both the United States and the European Union either have, or...more

King & Spalding

MDD Certificates Remain Valid: European Commission Proposes Longer Transition Periods for MDR Compliance

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On Friday, January 6, 2023, the European Commission adopted a proposal to give more time to certify medical devices in hopes of mitigating the risk of shortages in the European Union (EU). The proposal introduces a longer...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Hogan Lovells

ADG Insights | No, it's not only about China: Why EU businesses need to know about US Department of Defense and other US...

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Through ADG Insights, we share with you the top legal and political issues affecting the aerospace, defense, and government services (ADG) industry. Our ADG industry team monitors the latest developments to help our clients...more

Jones Day

An Assessment and Comparison of New TSCA and REACH

Jones Day on

Passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, or "New Toxic Substances Control Act," introduces a number of changes to regulations for the collection and assessment of information concerning...more

K&L Gates LLP

Medical Device Regulation Update

K&L Gates LLP on

On 5 May 2017, the Medical Device Regulation ("MDR") was published in the Official Journal of the European Union and comes into effect on 26 May 2017. The Commission proposed back in 2012 to revise the existing regulatory...more

Latham & Watkins LLP

The UK has voted to leave the EU: What now?

Latham & Watkins LLP on

The British public have voted that the UK should leave the EU. The EU Referendum vote (the Leave Vote) does not by itself result in an automatic UK exit from the EU. The EU Treaty provides for a framework for a...more

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