Category: Regulation & compliance

Productwise Battery Shorts, Part 4: New Supply Chain Diligence Obligations

In Part 4 of our ‘Battery Shorts’ series, we look at the new supply chain diligence requirements for companies under the European Union (EU) Batteries Regulation.

These requirements were originally due to apply from 18 August 2025, but the European Commission extended this date by two years, to 18 August 2027.

Emma Bichet, Julia Greaves, Edward Turtle

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.

Tracey Bischofberger, Edward Turtle

Cooley Litigation Trends Webinar Series – Marketplaces + Ecommerce

Please join Cooley’s litigation team for the next session of our continued legal education (CLE) webinar series, where we explore trends and insights on the disputes landscape in the UK and mainland Europe, and the issues that drive them.
Enrique Capdevila, Andrew Linch, James Maton, Claire Temple

Productwise Battery Shorts, Part 3: Substance Restrictions

In Part 3 of our ‘Battery Shorts’ series, we look at the substance restrictions under the new European Union (EU) Batteries Regulation, which have applied since 18 August 2024.

Julia Greaves , Edward Turtle

Productwise Battery Shorts, Part 2: Conformity Assessment and CE Marking Requirements

In Part 2 of our ‘Battery Shorts’ series, we look at the conformity assessment and CE marking requirements under the new European Union Batteries Regulation, which have applied since 18 August 2024.

If you are wondering whether the Batteries Regulation applies to your products, please see Part 1 of our series.
Julia Greaves , Edward Turtle

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’.

Julia Greaves , Edward Turtle

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

The EU’s General Product Safety Regulation: New Accident Reporting Obligations

In the third in a series of blogs on the General Product Safety Regulation, the Cooley products team unpacks the new accident reporting obligations being introduced across the European Economic Area (EEA) – made up of European Union Member States, plus Iceland, Liechtenstein and Norway – and Northern Ireland.

Rod Freeman , Claire Temple , Jamie Humphreys , Tracey Bischofberger