Med-Tech Innovation February 28, 2024
Ed Turtle and Anushi Amin, associates at law firm Cooley, analyse the new Product Liability Directive which will enter into force in 2024 and apply from 2026.
On 25 January 2024, the EU published the provisionally agreed text of a new Product Liability Directive (new PLD). The reforms are the biggest change to EU product liability rules in more than four decades, and we expect them to have a significant impact for the medtech industry. Here are five of the biggest changes:
1. More medtech products will be subject to claims
The definition of “product” under the new PLD has been extended beyond hardware, to include software, including standalone software, such as Software as a Medical Device (SaMD), and embedded...
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