On 28 September 2022, the Commission has published its proposal for a revised Product Liability Directive, and, for the first time a targeted harmonization of national liability rules for AI.

In a nutshell, the Commission´s proposal of a new Product Liability Directive implements rather extensive rules presuming defectiveness of the product and/or the causal link between its defectiveness and the damage for the benefit of the claimants. In addition, disclosure obligations for defendants are implemented to ease the position of the claimant, however, without considering a similar claim of the defendant against the claimant (e.g. in relation to medical records). For determining whether a product is defective, factors such as “product safety requirements” or “interventions by a regulatory authority or by an economic operator relating to product safety” have been added to the list of factors to be considered by courts when assessing defectiveness. This will become particularly relevant in the event a medical device has been recalled or was otherwise subject to a Field Safety Action.

At first glance, the new Product Liability Directive, will expose manufacturers of medical devices to significantly higher liability risks and has potential to hamper innovation, leading also to potentially higher product prices and reduced access to innovative medical devices. Some adjustments are still needed to achieve the fair balance between the two sides that has always been emphasized in the Commission´s proposal.

The Commission proposal must now be adopted by the European Parliament and the Council. It remains to be seen when and to what extent a political consensus will be found on all of the Commission’s proposals. As a rule, the Commission’s legislative proposals are expected to be adopted within 2 years, even if no deadlines are set in the legislative procedure. Member States must transpose the Directive 12 months after it enters into force and communicate the national execution measures to the Commission.

We have summarized some key aspects of the proposed Product Liability Directive in a Client Briefing.

For further information, please contact our Partner Marc Oeben.