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ARTICLE · 29 NOVEMBER 2024

EU Enforces Stricter Liability For Life Sciences Products

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Pharma and medtech companies face enhanced liability under the EU's new directive...

European UnionConsumer Protection

Pharma and medtech companies face enhanced liability under the EU's new directive

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The European Union has introduced a new product liability directive, replacing the previous directive 85/374/EEC, to address modern technological advancements and bolster consumer protection.

Effective December 2026, the legislation seeks to harmonise liability standards across the EU, compelling pharmaceutical and medical device companies to revise their product-related practices.

No-fault regime

The new directive (EU) 2024/2853 addresses the evolving landscape of product liability, particularly in light of advancements in technology, including artificial intelligence (AI), and the increasing complexity of global supply chains.

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