Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I work for a medical device company that put QM under operations 18 months ago. With this separation I am concerned that as the PRRC I am in a difficult  position as I have no input into QM. When I go to sign the DoC for a product how can i be sure that the device has been made following the requirements of the QM system. Do I have to review all of the files before I sign. Am I over thinking this or is it a potential problem. Does anyone have a view on this.

Regards

What do you mean by QM?  QC? QA? QMS?  And what does your company think these functions consist of?

Why don't you have input into QM?  I haven't given the PRRC role a lot of thought, but I can't imagine a scenario in which RA (if that is how you and your company see this role) has no input into QM.  No direct input, maybe, but no input, no.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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Original Message:
Sent: 04-Mar-2020 19:03
From: Anonymous Member
Subject: Person responsible for regulatory compliance

This message was posted by a user wishing to remain anonymous

I work for a medical device company that put QM under operations 18 months ago. With this separation I am concerned that as the PRRC I am in a difficult  position as I have no input into QM. When I go to sign the DoC for a product how can i be sure that the device has been made following the requirements of the QM system. Do I have to review all of the files before I sign. Am I over thinking this or is it a potential problem. Does anyone have a view on this.

Regards

Hello,

Is the Quality team aware of the exact responsibilities of the PRRC? If not, the PRRC responsibilities first need to be communicated to the Quality team (below for reference).

Then, once the information has been shared, there are a couple of options I can think of (there may be other ways):

• Ensuring that your function (PRRC) is designated as a reviewer for document types listed below (usually done through a reviewer approval matrix)
• If quality doesn't want the current PRRC function to have reviewer capability for quality management docs that are related to carrying out the responsibilities below - per MDR, you can designate multiple PRRCs (you + individual(s) in the quality team) and stipulate everyone's specific areas of responsibilities in writing, of course ensuring that each PRRC meets the qualifications listed.

Of course, as stated, there may be other ways of doing this, but the first step is to communicate the issue, because with a regulation as new and complex as MDR, all parties may not be aware of the nuances.

3.The person responsible for regulatory compliance shall 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;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 04-Mar-2020 19:03
From: Anonymous Member
Subject: Person responsible for regulatory compliance

This message was posted by a user wishing to remain anonymous

I work for a medical device company that put QM under operations 18 months ago. With this separation I am concerned that as the PRRC I am in a difficult  position as I have no input into QM. When I go to sign the DoC for a product how can i be sure that the device has been made following the requirements of the QM system. Do I have to review all of the files before I sign. Am I over thinking this or is it a potential problem. Does anyone have a view on this.

Regards

This message was posted by a user wishing to remain anonymous

Hi,

Was going through this post ... Wouldn't the responsibilities of the PRRC for legacy devices only be restricted to post market activities? 

What are the expectations of a PRRC for conformity assessment ?

Also currently our CEO is signing off the DOC, does it mean the PRRC will be responsible henceforth ( is this only for MDR compliant devices or also for legacy devices under the MDD ?)
Original Message:
Sent: 06-Mar-2020 10:29
From: Hiral Dutia
Subject: Person responsible for regulatory compliance

Hello,

Is the Quality team aware of the exact responsibilities of the PRRC? If not, the PRRC responsibilities first need to be communicated to the Quality team (below for reference).

Then, once the information has been shared, there are a couple of options I can think of (there may be other ways):

• Ensuring that your function (PRRC) is designated as a reviewer for document types listed below (usually done through a reviewer approval matrix)
• If quality doesn't want the current PRRC function to have reviewer capability for quality management docs that are related to carrying out the responsibilities below - per MDR, you can designate multiple PRRCs (you + individual(s) in the quality team) and stipulate everyone's specific areas of responsibilities in writing, of course ensuring that each PRRC meets the qualifications listed.

Of course, as stated, there may be other ways of doing this, but the first step is to communicate the issue, because with a regulation as new and complex as MDR, all parties may not be aware of the nuances.

3.The person responsible for regulatory compliance shall 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;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

------------------------------
Hiral Dutia
Sr. Regulatory Affairs Specialist
Third Pole Therapeutics
Waltham, MA
USA

Original Message:
Sent: 04-Mar-2020 19:03
From: Anonymous Member
Subject: Person responsible for regulatory compliance

This message was posted by a user wishing to remain anonymous

I work for a medical device company that put QM under operations 18 months ago. With this separation I am concerned that as the PRRC I am in a difficult  position as I have no input into QM. When I go to sign the DoC for a product how can i be sure that the device has been made following the requirements of the QM system. Do I have to review all of the files before I sign. Am I over thinking this or is it a potential problem. Does anyone have a view on this.

Regards

As Hiral said above by quoting the relevant article of MDR, the PRRC must ensure that the devices will be released to the market by fulfilling all MDR requirements.
MDR has requirements for technical documentation and QMS, including PMS and vigilance.

As I can see it, depending on the size of the company, the PRRC can practically be involved in all or almost none of these activities.
If a company is comprised of, let's say, 20 employees, an RA/QA manager might be able be involved in reviewing the QMS and be responsible for the technical documentation.
If a company has 500 employees, i believe that either the PRRC has a whole team performing the required activities, either he just reviews the final documents and checks in depth ,by a sampling procedure, only certain batches.
This is a common procedure with outsource QPs in pharmaceutical industry in many companies in Europe.

Don't forget that many SMEs will not have a PRRC in the company, thus it is not feasible for the PRRC to regularly check the QMS.

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 04-Mar-2020 19:03
From: Anonymous Member
Subject: Person responsible for regulatory compliance

This message was posted by a user wishing to remain anonymous

I work for a medical device company that put QM under operations 18 months ago. With this separation I am concerned that as the PRRC I am in a difficult  position as I have no input into QM. When I go to sign the DoC for a product how can i be sure that the device has been made following the requirements of the QM system. Do I have to review all of the files before I sign. Am I over thinking this or is it a potential problem. Does anyone have a view on this.

Regards

The concept of the PRRC is ideologically related to the QP in pharma.  One of the 'pesky points of note is clause (5).

5. "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."

Let's take a look at the concept of "suffers no disadvantage".  There are numerous situations occurring each day that puts organizational profitability at risk, and the PRRC is going to function as gatekeeper of those situations.  Many (most, based on my experience) high responsibility positions (such as a PRRC) have some level of their performance graded through PMS metrics, (i.e. reduction in NC and complaints) and are incentivized with bonus plans based either solely, or in part, to enterprise profitability. 

If the PRRC determines:

• A Lot or batch(s) should not be released
• A Product TF is inadequate and launch is delayed
• A FCA, withdrawal, or stop ship is enacted.

A PRRC incentivized this way could suffer a financial disadvantage when faced with making a negative organizational profitability decision (FCA, etc).

To provide the true independence necessary of the PRRC requires modification of current paradigms of personal performance objective strategies and compensatory plans for these key individuals and their internal organizations. This requires new thinking on organizational structure and reporting, roles and responsibilities, and compensatory and motivational systems for the PRRC.

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Michael Chellson
RAC
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Original Message:
Sent: 04-Mar-2020 19:03
From: Anonymous Member
Subject: Person responsible for regulatory compliance

This message was posted by a user wishing to remain anonymous

I work for a medical device company that put QM under operations 18 months ago. With this separation I am concerned that as the PRRC I am in a difficult  position as I have no input into QM. When I go to sign the DoC for a product how can i be sure that the device has been made following the requirements of the QM system. Do I have to review all of the files before I sign. Am I over thinking this or is it a potential problem. Does anyone have a view on this.

Regards