EUR-Lex Official Journal · November 09, 2024

EU Products Liability Directive (EU) 2024/2853 – National Transposition

Original title: EU Products Liability Directive - National Transposition

Directive clarifies 'product' definition to include digital manufacturing files and software, modernizing liability framework for AI-enabled devices and SaMD.

High obligation Framework Digital Health & AI Medical Devices & IVD General Regulatory EU-wide Software as a medical deviceMedical devicesAI governance

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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