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 !
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 !