MDR PRRC (person responsible for regulatory compliance) and personal liability

pkost

Trusted Information Resource
#1
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?
 
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shimonv

Trusted Information Resource
#2
Interesting...
We have not see a case of legal action taken against a PRRC.

Going forward, the RA manager will most likely be appointed PRRC. In the event of harm caused by illegal activity or serious/deliberate misconduct, the top management is most likely to be held accountable.
The PRRC has an area of responsibility, just like the VP R&D and VP OPS and VP Marketing.

The problematic PRRC requirement is:
"The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation."​
I don't really know what "shall suffer no disadvantage" means from a legal prospective without precedents. Hypothetically, if the PRRC identifies an event that warrants a recall he can voice his concern to top management ("shall suffer no disadvantage") but the other members of top management may think otherwise or the CEO may veto such a decision. If this thing blows-up with the PRRC in the organisation - I think all of them will be held responsible.

Perhaps the best approach is to have professional indemnity insurance for all top management.

As an independent consultant the PRRC requirements puts me in a very sensitive spot. Most likely I will never assume this role in an organisation.


Thanks for raising this point.
Shimon
 

SKM.Sunil

Involved In Discussions
#3
Interesting...
We have not see a case of legal action taken against a PRRC.
Going forward, the RA manager will most likely be appointed PRRC.
In the event of harm caused by illegal activity or serious/deliberate misconduct, the top management is most likely to be held accountable.
The PRRC has an area of responsibility, just like the VP R&D and VP OPS and VP Marketing.

The problematic PRRC requirement is:
"The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation."

I don't really know what "shall suffer no disadvantage"means from a legal prospective without precedents.
Hypothetically, if the PRRC identifies an event that warrants a recall he can voice his concern to top management ("shall suffer no disadvantage") but the other members of top management may think otherwise or the CEO may veto such a decision. If this thing blows-up with the PRRC in the organisation - I think all of them will be held responsible.

Perhaps the best approach is to have professional indemnity insurance for all top management.
As an independent consultant the PRRC requirements puts me in a very sensitive spot. Most likely I will never assume this role in an organisation.


Thanks for raising this point.
Shimon



shall suffer no disadvantage
Not like He will suffer employment related or financial or legal issues.

The EC is saying the PRRC must not be restricted to perform his duty, or his accessibility to areas of concern must not be restricted by the Organisation.

whether or not they are employees of the organisation
A Manufacturer can not disallow / non cooperative with the PRRC if it appoints any third-party.

I don't think it require a "professional indemnity insurance ".

but the other members of top management may think otherwise or the CEO may veto such a decision. If this thing blows-up with the PRRC in the organisation - I think all of them will be held responsible.
The PRRC by EUMDR is not a decision making authority and He can't make product recall, neither he is appointed by EC to monitor the manufacturer...still recall related decision is lies within top management or NB's order.

according to Article-13-3 c & d : the PRRC is responsible to make a report/ generate an analysis report for the activities carried out for article 87-91. (though he may not do it by himself)

The role of PRRC is like a position/responsibility that is similar to the MR, that requirement in a QMS
 
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