Products are becoming more complex in the digital age and with this increase in complexity, comes a potential increase in risk. In keeping up with the times, the European Commission published a proposal for a new directive on liability of defective products in September 2022. This would revise the existing Product Liability Directive, adopted nearly 40 years ago in 1985.
In response to this new update that has been proposed by the EU Commission, eleven prominent EU associations together with Med-Tech Europe, published a joint statement in which they voice their concerns about this proposed revision to the PLI Directive. From their statement published, they state that the proposed revision would remove the checks and balances and create a one sided, litigation friendly regime. The changes proposed will raise the litigation risk, legal complexity and uncertainty for EU business and companies will be put in a position where they have to allocate financial resources to either defend against unmeritorious claims or settle in attempts to limit the litigation costs and reputational risk.
These organisations do want to see a reform in the PLI directive that will cater for the new technology advances, however this should not be at the expense of innovation within the field.
They end their letter calling for a re-assessment of the revised PLD. They suggest the following:
- Limit the alleviation of the burden of proof.
- Safeguards for disclosure of evidence
- Scope fit for purpose.
The revision to the PLI directive can be accessed using the following link
The letter published by Med-Tech and other associations can be accessed using the following link
