Category: Key Developments
US Executive Order on AI Regulation Signals Litigation Risks Across Jurisdictions
A group of Cooley partners in Business, Communications, and CDP have authored an update on the recent US Executive Order seeking to limit US state AI regulation and establish a national AI policy framework. Multinational companies should monitor cross-border implications, especially in light of other evolving regimes like the EU […]
EU AI Act: Proposed ‘Digital Omnibus on AI’ Will Impact Businesses’ AI Compliance Roadmaps
This update covers the European Commission’s proposed “Digital Omnibus on AI”, published 19 November 2025. Part of the European Union’s simplification drive, the proposal aims to streamline the EU Artificial Intelligence (AI) Act’s implementation, ease compliance burdens and adjust compliance deadlines ahead of the AI Act’s full application on 2 August 2026.
Proposed Revision of EU’s New Legislative Framework for CE-Marked Products Looking to Expand Rollout of Digital Product Passports
The European Commission is working on a proposed revision of the New Legislative Framework (NLF) for CE-marked products, with plans to use this as a vehicle to roll out requirements for digital product passports (DPPs) to become the main tool for sharing product information in the European Union.
2025 ICPHSO International Symposium – Adapting to Change: Exploring the Future of Product Safety
The International Consumer Product Health and Safety Organization (ICPHSO) held its 2025 International Symposium on 14 and 15 October 2025, in cooperation with the UK Office for Product Safety and Standards (OPSS). The theme for this year’s international symposium was “Adapting to Change: Exploring the Future of Product Safety”.
Tracey Bischofberger, Rod Freeman
European Commission Publishes Guidance on EU Batteries Regulation Removability Requirements
New European Commission (EC) guidance on the European Union Batteries Regulation 2023/1542 has been published, which is relevant to anyone who places products containing batteries on the EU market. The new guidance sheds light on the challenging Article 11 requirement that portable batteries be ‘readily removable and replaceable by the end user at any time during the lifetime of the product’.
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson[1] upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices approved for one-time use.
Daniel Grooms, Andrew Goldstein, Zach Hafer, Sonia Nath, Matt Nguyen, Son Nguyen, Jim Santel
2024 – What a Year for Products Law! What’s Next in 2025?
The Cooley products team brings you a roundup of the highlights from Europe in 2024 and what to look out for in 2025.
Rod Freeman , Claire Temple , Tracey Bischofberger
One-Year Delay to EU’s Anti-Deforestation Law Confirmed
On 18 December 2024, the Council of the EU formally adopted the regulation delaying the application of the European Union’s Deforestation Regulation (EUDR) by 12 months. This follows the European Parliament’s formal adoption of the amending regulation on 17 December 2024. Now that the final legislative hurdles have been overcome, the amending regulation must be signed and published in the Official Journal of the European Union so that it can become law before the end of the year. This delay means that businesses now have until 30 December 2025 to ensure they have procedures in place to comply with the EUDR.
One-Year Delay to EU’s Anti-Deforestation Law Close to Approval
On 3 December 2024, provisional agreement was reached on the proposal to delay the application of the European Union’s Deforestation Regulation (EUDR) by 12 months. According to the provisional agreement, the targeted amendment will not affect the substance of the existing legislation as it was originally agreed. The EUDR only allows in-scope products and commodities that are ‘deforestation-free’ to be placed or made available on the EU market and/or exported from the EU. This includes certain products made from cattle, wood, cocoa, soy, palm oil, coffee and rubber.
It’s Official! Europe’s Product Liability Rules Enter Into Force on 9 December 2024
The European Union’s Product Liability Directive (PLD) has been published and will enter into force on 9 December 2024. A 24-month transition period means that the new PLD regime will apply in EU member states by 9 December 2026.