Revision of EU Product Liability Directive and Medical Device Risk Management

[MED-T1]

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!

 

[yodon]

Interesting question. The thought that jumps to my mind would be what could one do to control harm to psychological health? Exclude patients that might be prone to such things? Send each patient to pre-procedure counseling? (I don't believe either would be realistic.) And how would it be "proven" that harm to psychological health actually occurred (and to what extent)? Seems like anyone could claim that hoping for compensation. Seems like it would be opening (another) can of worms. So that probably means that, indeed, we will have to address it in risk management.

 

[Chrisx]

It might be applicable for certain devices, like deep brain stimulation for Parkinson's. I would imagine the wrong stimulation to the brain would have a psychological impact. It may already be covered in the risk management file for devices used on the brain.