Is Your Insurance Policy Ready for the New EU Product Liability Directive?

Is your insurance policy ready for the biggest shake-up in EU product liability in 40 years?

About this Whitepaper

A major shift is coming for manufacturers, distributors, and suppliers across the EU. The new Directive (EU) 2024/2853 on Product Liability, effective from 9 December 2026, replaces a 40-year-old framework — and it fundamentally changes who can be held liable and what damages can be claimed.

What’s changing?

Broader definition of “product” – software, digital files, and even updates are now included.
Expanded damages – claims can cover psychological harm and data loss, not just physical damage.
Wider liability chain – not only manufacturers, but also authorised reps, importers, logistics providers, and in some cases distributors may face liability.
Strict liability principle remains – no proof of negligence is needed for claims to succeed.

Why it matters for your business

This expanded liability framework means your insurance coverage may no longer be sufficient. Policies need to be reviewed and adapted to cover:

Software and digital components
Psychological harm and data loss
Circular economy activities (repairs, remanufacturing, reuse)
Cybersecurity vulnerabilities in connected devices

The Directive also ties closely with MDR/IVDR obligations, raising the stakes for compliance and risk management.

Take action now

The countdown to 2026 has begun. Businesses across the medtech and life sciences sector need to reassess their risk exposure and ensure their insurance truly protects them under the new rules.

👉 Our full white paper explores the Directive in detail and provides practical steps to get your insurance policy ready.

Download the White Paper below