With the upcoming revision to the EU Product Liability Directive, which I believe is likely to be approved in the next couple of months, I was wondering if there would be knock-on impacts to what needs to be considered through medical device risk management activities? In the revision there is an expanded definition of 'damage' to include 'medically recognised harm to psychological health'. In light of that should product risk be considering this as an additional set of potential harms? Or am I overthinking the ramifications of the new PLD legislation?
Thanks!
Thanks!