ARTICLE SUMMARY:
Lurking within the jumble of pending EU new and revised legislation likely to impact device companies is the proposed product liability directive. While not medtech-specific, this industry-wide proposal could have a significant impact on innovative devices by increasing litigation and boosting insurance costs on companies worldwide looking to market products in Europe.
2024 promises to be a big year in terms of major new European legislation and directives—some medtech-specific, others more broad-based but affecting medtech—that will significantly impact the device industry globally in terms of companies that market their products in Europe. Much of this could occur in the first half of the year, spurred by the upcoming EU elections in June. From possible revisions to the recently implemented Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to more wide-ranging enactments covering artificial intelligence (AI) and broadly regulating data usage, there is an abundance of major proposals that are currently on the threshold of becoming law that will affect device companies.
One such proposal is perhaps not as well known to the device industry as those mentioned above, but may nonetheless pose a potentially significant risk to product companies and that is the proposed revised EU product liability directive (PLD). The current standard was adopted in 1985 and in light of the growth of increasingly complex technologies—most notably digital—over the ensuing nearly 40 years, the European Commission decided that it was time to update the PLD and introduced the proposed new directive in September 2022.
