The European Union adopted a revised Product Liability Directive (PLD) at the end of 2024, to be implemented into the national Member States' product liability laws by end of 2026.

Economic operators' liability for products put into circulation after 8 December 2026 will be subject to broader material liability rules (e.g., extended definitions of product, liability subject, defect and compensable damages) and novel procedural mechanisms (e.g., access to evidence and rebuttable factual presumptions for the defectiveness of the product and/or for the causal link between the alleged defect and damage as well as a longstop expiry period in case of latent personal injury).

As of January 2026, snapshots of four selected EU jurisdictions show that implementation of the new harmonized EU product liability rules remains fragmented halfway through the transposition period:

• In Germany, a draft bill approved by the Federal Government in mid-December 2025 is currently in the parliamentary process. As it stands, the draft almost literally transposes the PLD's changes to the current German product liability act. However, the sectoral exemption for the liability for medicinal products shall continue to apply.
• In Italy, the legislative delegation for transposition of the PLD has been granted. Although the legal framework for transposition is in place, no draft implementing measures have yet been published, and the substantive provisions of the new product liability regime are still to come.
• In France and Spain, no legislative initiative had been undertaken to begin the transposition as of 31 December 2025. A delayed implementation is a realistic scenario given France and Spain's track record of lagging behind on the transposition of EU directives. Also, the executive is not particularly stable at the moment in both countries, which may contribute to legislative delays.

From a practical perspective, the key issue is not merely whether Member States will transpose the new PLD on time, but also how businesses prepare for the new national rules.

The continued anticipation of core legislative changes will be paramount in 2026 for businesses operating in the EU life sciences and health care sector, who should be identifying and preparing for the new procedural mechanisms and broader material liability rules as it applies to both their company and their products.