New Product Liability Directive Proposal | Medical Devices/IVDs

More than 30 years since the Product Liability Directive (PLD) was established and after the Commission assessed its regulatory fitness and performance prior to the COVID-19 pandemic, at the end of September 2022, the Commission finally adopted a proposal to update the PLD so that it be more ‘fit for purpose’ in the context of modern technology and address several shortcomings in the original directive. 

While currently only a proposal, there are some early takeaways for entities in the supply chain of placing medical devices/IVDs on the market which we discuss here: 

What about defective performance?

A fundamental principle of the MDR/IVDR is that devices placed on the market or put into service conform with applicable General Safety and Performance Requirements (GSPR), with consideration for the intended purpose of the device. Yet Article 6 of the PLD proposal states that “a product shall be considered defective when it does not provide the safety which the public at large is entitled to expect, taking all circumstances into account” with several circumstances to be taken into account listed in the proposal. In other words, in a scenario where a device does not meet the manufacturer’s performance claims, but is safe, the proposal does not establish requirements.

Supply chain entity liability

The only entities for which there are references to liability in the MDR/IVDR are manufacturers, authorized representatives and notified bodies. However, under Article 7 of the Product Liability Directive proposal, liability for defective product extends to other entities throughout the supply chain, including: 

• • • Component manufacturers: The proposal states that where a defective component has caused the product to be defective, the manufacturer of a defective component can also be held liable for the same damage. 
    • Importers: Where manufacturers are established outside of the Union, the proposal states that both the authorized representative and the importer can be held liable. 
    • Distributors: Where a manufacturer cannot be identified OR where the manufacturer is located outside the Union, and neither an authorized representative nor importer can be identified, each distributor of the product can be held liable under specific circumstances laid out in the PLD. 

• • • Online platform providers: Such providers that allow consumers to conclude distance contracts with traders and are not manufacturers, importers, or distributors are also liable if certain conditions are fulfilled. An overseas-based laboratory with an online platform through with EU residents can request laboratory diagnostic testing services to be performed in the laboratory could be a theoretical example of such an entity.

Off-label use liability 

MDCG 2020-3 and MDCG 2022-6 both provide guidance on significant changes within the context of the transitional provisions however both include guidance regarding what constitutes a significant change in the intended use of a device. The NLD proposal states under Article 7 that any natural or legal person that modifies a product already on the market or put into service will be considered a manufacturer for the purposes of liability against damages caused by this product. This would appear to apply to healthcare professionals using devices in an off-label manner, but this may be better clarified in future changes to the proposal.

The proposal will no doubt undergo several amendments before being established as Union legislation, and the above are only a sample of some of the proposed requirements. Some significant considerations for device manufacturers, particularly regarding supply chain entities, already exist.

If you have any additional questions regarding the new Product Liability Directive proposal, contact us!