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PRRC effective role and activities

#1
Hi all !
I understand the theorical role of the PRRC (person responsible for regulatory compliance) as described in the MDR.

I do have a question on the practical role of this person on a day-to-day basis.
Is there activities that require to be exclusively performed by the PRRC ?

Is batch release one of the activities that need to be performed by the PRRC ?
Is the PRRC has to systematically sign some document (declaration of conformity, change control etc...) ?

If this person is an external of the company (small business), how do she/he ensure his/her role ?
Should he/ she have to perform a seasonal audit to ensure that the activities are performed in compliance ?
If so, how this audit is different from a regulatory compliance mock audit ?

So many questions !
Thanks a lot for your answers !
 
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#2
Is there activities that require to be exclusively performed by the PRRC ?
I would say the activities that are exclusive to the PRCC include managing regulatory submissions, determination of whether changes affect existing regulatory filings, and determination of whether a complaint or adverse event should be reported to a regulatory authority.

Is batch release one of the activities that need to be performed by the PRRC ?
No. In my experience, this is performed by someone in the quality assurance or quality control group.

If the person is external to the company, it is important for a person within the company to know when to call on the PPRC when needed. Typically, as the company matures, the will see that they need their own regulatory person. External entities typically specialize in assisting companies with their first regulatory submission.
 
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