After the political agreement on the revision of the Product Liability Directive (PLD), reached on 14 December 2023 by the European Council and Parliament, new concerns were expressed by MedTech Europe on behalf of the European medical technology sector. According to a note published on its website, the overall impact of the revised PLD on companies and consumers, and on the medical technology sector, would have not been properly considered.
According to MedTech Europe, the revised PLD resulting from negotiations would lack meaningful safeguards to ensure that a reversal of the burden of proof is only applied when very specific conditions are met. This could present issues for companies, as the newly introduced presumptions may lead to an increased volume of legal claims resulting in higher insurance costs, dampening innovation, and putting at risk smaller companies. The current wording would also not ensure the right to a fair trial for both sides. MedTech Europe identifies Recital 34 of the agreed text as particular critical and suggests co-legislators should consider the European Parliament’s position in the final text in order to ensure that innovative medical technology’s complexity is assessed fairly.