PRRC liability transfer

MarRz

Involved In Discussions
Hello,

Does anyone have experience with how PRRC liability could be transferred to the company? So that in the event of financial liability, the company will pay the fine.

In the event that a bug in IVDR medical device software leads to harm or death of the patient, can PRRC be sued or put in jail? Can this liability also be transferred to the company?

Any other information about PRRC liability are also welcome since this is a new and relatively unknown area for me. :)


Thanks,
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I dont think the PRRC would be criminally liable unless there was fraud or omission in a filing. The PRRC assures the device is provided according the regulations. It's 100% possible a device meets regulations and is implicated in death or serious injury. This does not imply punishment for the PRRC at all.
 

shimonv

Trusted Information Resource
Well, you have two options: to purchase insurance policy privately or to ask the company to add you, specially, to their business insurance policy. Legal action against PRRC is quite rare; I am no lawyer but for that they have to show criminal negligence. A discovery of a new software bug happens every day...
 

MarRz

Involved In Discussions
Is it acceptable if the company director issues a statement that the company will cover all PRRC's liability instead of getting an insurance policy?
 

shimonv

Trusted Information Resource
Better to consult a lawyer...
My two cents: better to be covered by a policy (third party) than a transient Director.
 
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