EUR-Lex Official Journal · November 09, 2024

EU Products Liability Directive (EU) 2024/2853 – National Transposition and Digital Product Coverage

Original title: EU Products Liability Directive - National Transposition

New Products Liability Directive expands 'product' definition to explicitly include digital manufacturing files and software, affecting AI-enabled medical devices and SaMD.

High impact Medical Devices Digital Health & AI General Regulatory EU-wide samdai-governancemedical-devices

Member States must transpose new Products Liability Directive (EU) 2024/2853 into national law. Directive clarifies 'product' definition to explicitly include digital manufacturing files and software. Critical for AI-enabled medical devices, SaMD, and digital health products. Modernizes liability framework for new technologies and circular economy business models.

Dates and deadlines

Implementation Date

December 09, 2026

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Published by EUR-Lex Official Journal. HealthSignal links to the original document; the summary above is extracted from the source text.