News & Analysis as of

Manufacturers Distributors European Union

Foster Garvey PC

U.S. Businesses Must Prepare for EU Accessibility Act Compliance by June 28

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The European Accessibility Act (“EAA”) takes effect across the European Union on June 28, 2025, for new products and services in the EU market. Products and services already on the market have a longer transitional period...more

Herbert Smith Freehills Kramer

Accessibility Directive: Final countdown before application on 28 June 2025 - Businesses will be required to comply with new...

On 28 June 2025, businesses will be required to comply with accessibility requirements applicable across the European Union (EU) for a broad range of products and services. These obligations stem from Directive (EU) 2019/882...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

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

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Hogan Lovells

The CJEU reinforces the liability of the distributor in claims for damages for defective products

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The Court of Justice of the European Union (CJEU) reinforces the liability of the distributor in claims for damages caused by defective products in cases of identity between the name of the distributor and the brand it...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

BCLP

Key Insights on the EU Cyber Resilience Act - What Businesses Need to Know

BCLP on

The Cyber Resilience Act (CRA) is a groundbreaking piece of legislation designed to enhance the cybersecurity of digital products and services made available in the EU. Published last week in the Official Journal of the...more

Proskauer Rose LLP

EU's AI Act: Ten Facts for Organisations in the UK and US

Proskauer Rose LLP on

The EU’s AI Act (the “Act”) is the world’s first comprehensive AI law. The Act manages risks posed by certain AI systems and prohibits certain AI-related practices. UK and US organisations should not assume that the Act does...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s AI Act: A Review of the World’s First Comprehensive Law on Artificial Intelligence and What This Means for EU and Non-EU...

The agreed text of the AI Act was published on July 12, 2024, essentially starting the clock on the legal deadlines contained in it. Its obligations will apply in tiered phases, with the first key obligations being enforced...more

Pillsbury - Internet & Social Media Law Blog

The EU and UK Introduce New IoT Security Standards

The FCC’s recent introduction of a new Voluntary Cybersecurity Labelling Program for consumer Internet of Things (IoT) products reflects the continued desire by U.S. regulators to bolster the security of the ever-increasing...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

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

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In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

King & Spalding

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

King & Spalding on

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

K&L Gates LLP

Surge of Antitrust Enforcement Against Manufacturers of Branded Consumer Goods

K&L Gates LLP on

European antitrust regulators have shown a continued focus on scrutinizing manufacturers’ engagement with their distributors. The anticompetitive practices that have attracted the highest financial penalties primarily relate...more

Jones Day

French Court Clarifies Surveillance Obligations

Jones Day on

The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more

Jones Day

France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States

Jones Day on

On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more

Hogan Lovells

Brexit – what’s next for medical devices?

Hogan Lovells on

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products,...more

Sheppard Mullin Richter & Hampton LLP

Scrambling After an Egg Crisis – EU Safety Guidance for Online Product Sales

EU food safety authorities are still feeling the repercussions of the insecticide-contaminated eggs crisis. That crisis highlights the many challenges of dealing with unsafe and non-compliant products in a single European...more

Sheppard Mullin Richter & Hampton LLP

On the Way to a European Digital Single Market: Whether You Sell Online or Offline – Listen Up!

The European Commission’s Directorate-General for Competition has issued a lengthy preliminary report of its ongoing sector inquiry into the e-commerce of goods and digital content. The sector-wide inquiry was launched on May...more

Morrison & Foerster LLP - Structured Products

Structured Thoughts: News for the financial services community, Volume 7, Issue 8

Brexit and Structured Products: A Framework for Considering Disclosures - The U.K.’s recent referendum to withdraw from the European Union has affected virtually all segments of the financial industry. The structured...more

Robinson & Cole LLP

Data Privacy: A Bill in Congress Every Manufacturer Should Be Aware of

Robinson & Cole LLP on

One of the issues that manufacturers/distributors are paying more attention to is their document retention policies. Things get complicated, however, when a corporation has operations outside of the United States. It is not...more

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