Module 17 2024

04/12/2024

TOPRA MSc Module 17

Medical Device Product Liability

4 December 2024

Elizabeth-Anne Larsen, Senior Associate – Solicitor Advocate, CMS Cameron McKenna Nabarro Olswang LLP E: elizabeth-anne.larsen@cms-cmno.com T: +44(0)207 524 6115

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA MSc Module 17

1

Overview

• Product safety vs. product liability • Product Liability and some pipeline developments – Contract – Negligence – ‘Strict Liability’ under the new Product Liability Directive 2024/2853/EU (New EU PLD) – Recent legal decisions on ‘defect’ • Interaction between the EU MDR and the EU product liability framework

2

TOPRA MSc Module 17

2

1