Regulatory Open Forum

According to MDCG2019 shall "The person responsible for regulatory compliance  at least be responsible for
ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the
quality management system under which the devices are manufactured, before a
device is released;"

If the performance of the release is delegated by the PPRC to another employee is it required that this individual then fulfills the PRRC qualification requirements?

Thanks in advance!
Kind regards,
Malin

------------------------------
Malin Kylberg
Director QA & Regulatory Compliance
OssDsign
Uppsala
Sweden
------------------------------

MDCG 2019-07 responds to this requirement (the requirement for medical device quality control) by giving a general referral to the organization's associated quality management system intended to ensure compliance "...in the most effective manner..." and "...proportionate to the risk class...".

Accordingly, my approach is that the PRRC assures compliance with this requirement by way of proper corresponding quality management system elements.  Specifically, for high-risk devices, it may be suitably proportionate and most effective that the PRRC is the final approver of device releases (final, in-process, etc., commensurate with risk).  In contrast, for low-risk devices, it may be enough that the PRRC simply review (such as via internal audit) the release records on a periodic basis, or perhaps even enough that the quality management system simply contains the appropriate QC provisions that are executed and audited by persons other than the PRRC.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 21-Jan-2022 09:35
From: Malin Kylberg
Subject: Qualification requirements if performance of release is delegated by the PRRC?


According to MDCG2019 shall "The person responsible for regulatory compliance  at least be responsible for
ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the
quality management system under which the devices are manufactured, before a
device is released;"

If the performance of the release is delegated by the PPRC to another employee is it required that this individual then fulfills the PRRC qualification requirements?

Thanks in advance!
Kind regards,
Malin

------------------------------
Malin Kylberg
Director QA & Regulatory Compliance
OssDsign
Uppsala
Sweden
------------------------------

Hi Kevin and Malin

I would approach it by using having QMS  processes in place, including release criteria.

Don't try to make this PRRC  into a Qualified Person role, as in Pharma.  Then there could really be a problem, especially if the PRRC was to quit. Yes, there are qualification requirements for the PRRC, but they are not as onerous as those for a QP, and defining the PRRC as having to release product could be problematic..










------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 21-Jan-2022 13:09
From: Kevin Randall, RAC
Subject: Qualification requirements if performance of release is delegated by the PRRC?

MDCG 2019-07 responds to this requirement (the requirement for medical device quality control) by giving a general referral to the organization's associated quality management system intended to ensure compliance "...in the most effective manner..." and "...proportionate to the risk class...".

Accordingly, my approach is that the PRRC assures compliance with this requirement by way of proper corresponding quality management system elements.  Specifically, for high-risk devices, it may be suitably proportionate and most effective that the PRRC is the final approver of device releases (final, in-process, etc., commensurate with risk).  In contrast, for low-risk devices, it may be enough that the PRRC simply review (such as via internal audit) the release records on a periodic basis, or perhaps even enough that the quality management system simply contains the appropriate QC provisions that are executed and audited by persons other than the PRRC.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 21-Jan-2022 09:35
From: Malin Kylberg
Subject: Qualification requirements if performance of release is delegated by the PRRC?


According to MDCG2019 shall "The person responsible for regulatory compliance  at least be responsible for
ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the
quality management system under which the devices are manufactured, before a
device is released;"

If the performance of the release is delegated by the PPRC to another employee is it required that this individual then fulfills the PRRC qualification requirements?

Thanks in advance!
Kind regards,
Malin

------------------------------
Malin Kylberg
Director QA & Regulatory Compliance
OssDsign
Uppsala
Sweden
------------------------------

Hi Kevin, GInger and Eric,

Thanks for your valuable input putting light and giving clarity on the PRRC responsibilities, role and requirements in correlation to the release process.

Your point Ginger is also very intresting with comparisoin between PRRC and QP since since this  thinking of them as equal is easily made.

Kind regards,
Malin



------------------------------
Malin Kylberg
Director QA & Regulatory Compliance
OssDsign
Uppsala
Sweden
------------------------------

Original Message:
Sent: 22-Jan-2022 07:59
From: Ginger Cantor
Subject: Qualification requirements if performance of release is delegated by the PRRC?

Hi Kevin and Malin

I would approach it by using having QMS  processes in place, including release criteria.

Don't try to make this PRRC  into a Qualified Person role, as in Pharma.  Then there could really be a problem, especially if the PRRC was to quit. Yes, there are qualification requirements for the PRRC, but they are not as onerous as those for a QP, and defining the PRRC as having to release product could be problematic..










------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 21-Jan-2022 13:09
From: Kevin Randall, RAC
Subject: Qualification requirements if performance of release is delegated by the PRRC?

MDCG 2019-07 responds to this requirement (the requirement for medical device quality control) by giving a general referral to the organization's associated quality management system intended to ensure compliance "...in the most effective manner..." and "...proportionate to the risk class...".

Accordingly, my approach is that the PRRC assures compliance with this requirement by way of proper corresponding quality management system elements.  Specifically, for high-risk devices, it may be suitably proportionate and most effective that the PRRC is the final approver of device releases (final, in-process, etc., commensurate with risk).  In contrast, for low-risk devices, it may be enough that the PRRC simply review (such as via internal audit) the release records on a periodic basis, or perhaps even enough that the quality management system simply contains the appropriate QC provisions that are executed and audited by persons other than the PRRC.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 21-Jan-2022 09:35
From: Malin Kylberg
Subject: Qualification requirements if performance of release is delegated by the PRRC?


According to MDCG2019 shall "The person responsible for regulatory compliance  at least be responsible for
ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the
quality management system under which the devices are manufactured, before a
device is released;"

If the performance of the release is delegated by the PPRC to another employee is it required that this individual then fulfills the PRRC qualification requirements?

Thanks in advance!
Kind regards,
Malin

------------------------------
Malin Kylberg
Director QA & Regulatory Compliance
OssDsign
Uppsala
Sweden
------------------------------

Hi Malin, if the PRRC delegates it is not required that the person delegated to also fulfills the qualifications for the PRRC, because the PRRC has the final responsiblity. But, the PRRC remains repsonsible for overseeing functioning of the quality system on this point so (s)he must receive reporting/information suitable to bear responsibility for the QMS process.
Best regards,
Erik

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 21-Jan-2022 09:35
From: Malin Kylberg
Subject: Qualification requirements if performance of release is delegated by the PRRC?


According to MDCG2019 shall "The person responsible for regulatory compliance  at least be responsible for
ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the
quality management system under which the devices are manufactured, before a
device is released;"

If the performance of the release is delegated by the PPRC to another employee is it required that this individual then fulfills the PRRC qualification requirements?

Thanks in advance!
Kind regards,
Malin

------------------------------
Malin Kylberg
Director QA & Regulatory Compliance
OssDsign
Uppsala
Sweden
------------------------------