The MDR introduces the role of "person responsibile for regulatory compliance". It specifically identifies their role and responsibilities and sets the apart from the legal entity that is the manufacturer by saying that they cannot be disadvantaged in their employment as a result activities related to the role
I haven't seen much debate around personal liability for this individual and am somewhat concerned about how it will play out in the event of a device causing harm to a patient/user
Has anyone else given this consdieration, is anyone considering taking out professional indemnity insurance?
I haven't seen much debate around personal liability for this individual and am somewhat concerned about how it will play out in the event of a device causing harm to a patient/user
Has anyone else given this consdieration, is anyone considering taking out professional indemnity insurance?