My 2 cents:
Per MDR Article 15: "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."
If an employee is assigned the PRRC role, I would not expect them to take on any personal liability. Liability should still rest with the company and company officers (top management).
If the PRRC function is outsourced, I would expect a full agreement in line with how other outsourced processes are handled as well as some insurance. There is a thread about personal liability insurance for externally appointed PRRCs on the forum that Anon should review.
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Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
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Original Message:
Sent: 09-Mar-2021 09:03
From: Christian Micheletti
Subject: PRRC - Salary increase
Hi,
I have no idea about salary increase. Given the importance of the job, I would not rule that out, and I would not discount it as "other duties as assigned". It is not like being assigned a vigilance duty on a device in addition to other tasks.
Given the increased legal liability and responsibility linked to the role, including a mandate between company and PRRC to be accepted by both parties, I would take the role with great awareness. For example, I would look for an insurance coverage by the company. I would not be forced to sell my house to pay for damages.
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Christian Micheletti
Project Manager; Regulatory Affairs expert
Zurich
Switzerland
Original Message:
Sent: 04-Mar-2021 10:42
From: Anonymous Member
Subject: PRRC - Salary increase
This message was posted by a user wishing to remain anonymous
Hi,
which could be the right salary increase for a Quality Manager that is also appointed PRRC for the EU MDR?