Revised Product Liability Directive: Financial And Operational Challenges For Medtech Companies

The provisionally agreed EU’s Product Liability Directive is set to place the burden of proof on medtech companies and extend the latent damage clause from 10 to 25 years. Both updates will have financial and operational impacts on the medtech industry.

Legislation
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In December last year, the European Union reached a provisional political agreement on the text for the proposed revision of the EU’s Product Liability Directive (PLD).

The updates aim to bring the directive up to speed with technology innovation, expanding the scope to include software (e.g.,...

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