MedTech Europe position paper on the revision of the Product Liability Directive
The European Commission is revising the Product Liability Directive (PLD). The priority in any PLD revision must be that it continues to uphold an established balance which fosters safe innovation, offers legal certainty and consistency with the existing legal frameworks, and allows consumers to claim compensation if they suffer injury arising from defective products. Undermining this balance risks disrupting incentives to innovation, which is needed to provide state-of-the-art technologies that address the unmet needs of consumers and patients.
The medical technology sector is regulated through modern and extensive sector-specific safety legislation (i.e., Medical Device Regulation (MDR), In Vitro Diagnostic Medical Devices regulation (IVDR)). The combination of these complex pieces of legislation ensures the safety and performance of medical technologies, along with world-class data protection and product liability standards.
Given this context, MedTech Europe believes that the PLD in its current form is still fit for purpose. Where new emerging digital technologies and associated services make certain clarifications necessary, guidance should be published to address such developments.
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Posted on 28.09.2022