Hi Anon,
I agree with Markus that liability in relation to the PRRC is not described in the MDR/IVDR.
I also would like to add that according art. 15.5, "the PRRC shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties." A safeguard against regulatory rightful decisions (as documented and assured in the QMS), but maybe not directly satisfactorily from a "business" point of view (disagreement on a final release, or on reporting vigilance issues,...).
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
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Original Message:
Sent: 12-Mar-2021 02:16
From: Markus Lantermann
Subject: PRRC, who is accountable/liable?
Hello,
the MDR/IVDR doesn´t describe any personal liability related to the PRRC. So the company remains liable for compliance issues (other than e.g. the QP in the pharma world). For this, the company needs to be ensured adequately.
However, the missing personal liability may not safeguard company-internal rules on liability.
Hope this helps - Best Regards
Markus
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Markus Lantermann
Head of Q&R Region International
Mannheim
Germany
Original Message:
Sent: 11-Mar-2021 13:34
From: Anonymous Member
Subject: PRRC, who is accountable/liable?
This message was posted by a user wishing to remain anonymous
For major compliance issues who is accountable/liable ?
I review the MDCG guidance document but still didn't get a clear answer.
Can a PRRC be held accountable/liable for major compliance issues ?