Post-market activities including PMS and product liability

2025年7月

6 观点

6 观点

A new era for product liability in the EU

This article outlines the key changes introduced by the new PLD. It explores the expanded scope of liability and the broader pool of potentially liable parties, as well as the new rules on the burden of proof and disclosure of evidence.

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Insights from Member States: What can we expect from the new Product Liability Directive?

The new Product Liability Directive introduces significant changes to the EU’s product liability regime in the EU. Member States must implement it by December 2026. But what will its biggest challenges be? How can businesses prepare for and mitigate the new product liability risks in the EU?

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Product Liability Directive: Are you ready for its Article 9 disclosure obligations?

The New EU Directive on Liability for Defective Products modernises the current EU legislation to bring it up to date with our ever-evolving digital environment. One particularly significant change is the extended disclosure burden. In this article we examine why this burden is particularly difficult for multi-national life sciences businesses and explain the steps you should be taking now to mitigate against potential court sanctions for failure to disclose relevant evidence.

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Medical devices: additional regulatory considerations from the new liability frameworks

In this article we examine why this burden is particularly difficult for multi-national life sciences businesses and explain the steps you should be taking now to mitigate against potential court sanctions for failure to disclose relevant evidence.

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Corrective actions: dos and don’ts

This article sets out a summary of the key dos and don’ts for preparing for and managing corrective action in the life sciences sector.

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Drafting PMS and vigilance obligations into medical device distribution agreements

In this article we discuss here how manufacturers might ensure, through appropriate contractual provisions, that distributors (and importers) will provide all necessary support to allow a manufacturer to comply with its PMS obligations.

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