News & Analysis as of August 4, 2025

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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 WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

New MDCG guidance clarifies rules for medical device software available on online platforms

Hogan Lovells on 6/19/2025

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

EU Cyber Resilience Act: How to Prepare Now

Mitratech Holdings, Inc on 5/16/2025

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

Ten Things to Know About the European Union’s New Product Liability Directive

Faegre Drinker Biddle & Reath LLP on 4/18/2025

After it was initially proposed more than two years ago, the European Union passed a new product liability directive (PLD) on Dec. 9, 2024, which prescribes a new legislative framework to expand and modify product liability...more

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

Pillsbury Winthrop Shaw Pittman LLP on 4/16/2025

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

Indirect patent infringement before the UPC: limits that manufacturers must observe in advertising and product instructions

A&O Shearman on 4/2/2025

Ortovox Sportartikel GmbH v. Mammut Sports Group AG/GmbH (UPC_CFI_16/2024), Düsseldorf Local Division (January 14, 2025) ORD_63219/2024. Anyone developing or marketing an innovative product will want to ensure that they do...more

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

Goodwin on 2/18/2025

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

The EU Updates its Products Liability Directive to Include AI

Fenwick & West LLP on 12/13/2024

On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....more

Radical Changes to Europe's Product Liability Rules Adopted

Jones Day on 12/2/2024

Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on 11/26/2024

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

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

Proskauer Rose LLP on 11/13/2024

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

EU Adopts Cyber Resilience Act for Connected Devices

Goodwin on 10/15/2024

On October 10, 2024, the European Council officially adopted the Cyber Resilience Act (CRA), a regulation designed to ensure that products with digital features are secure to use and resilient against cyber threats, and that...more

Data Act Frequently Asked Questions Answered by the EU Commission

DLA Piper on 9/26/2024

The EU Data Act is one of the cornerstones of the EU's Data Strategy and introduces a new and horizontal set of rules on data access and use to boost the EU's data economy. Most of the provisions of the Data Act will become...more

Preparing for the EU Cyber Resilience Act

Venable LLP on 1/23/2024

The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

EU Reaches Legislative Deal on Proposed ‘Digital Age’ Updates to Product Liability Directive

Faegre Drinker Biddle & Reath LLP on 12/18/2023

This week, the European Union made a significant breakthrough towards its goal of overhauling the 40-year-old Product Liability Directive for the demands of the “digital” age and modern economy. To amend the directive, the...more

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

MoFo Life Sciences on 6/14/2022

Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

EU: IN VITRO Diagnostic Regulation Entered Into Force (Part 1 OF 3)

MoFo Life Sciences on 5/31/2022

In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 Of 6)

MoFo Life Sciences on 3/24/2021

The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated...more

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

MoFo Life Sciences on 2/25/2021

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

Robins Kaplan LLP on 12/2/2019

The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of currencies in both South American nations....more

Is Your Medical Device Software Compliant with the New EU Standards?

Miles & Stockbridge P.C. on 8/31/2017

The IEC 62304 standard specifies life cycle requirements for the development of medical software and software within medical devices. It is a standard that is harmonized between the European Union (EU) and the United States...more

International Product Liability Review - Issue 65

Hogan Lovells on 2/15/2017

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more

Toys Not Immune from Scrutiny Over Privacy and Security Weaknesses

Robinson+Cole Data Privacy + Security Insider on 12/21/2016

In the wake of the holiday season, it seems that even toys are not immune from privacy and security pitfalls. Two “connected” toys, Genesis Toys’ My Friend Cayla and i-Que robot, have been accused of violating U.S. and...more

New EU Rules for Medical Devices

Sheppard Mullin Richter & Hampton LLP on 7/13/2016

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

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