Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Help! If a company has falsely self-certified its on market products as IVDD and does not have the respective requirements for the Essential Requirements Checklist, such as Quality Management System or other technical documents to support its self declaration and product labeling, what is the risk to the person responsible for the Quality and Regulatory of the company? Who takes the fall if the authorities discover this? Is this a whistleblow opportunity if top management does not take action?

Dear Colleague,

I think all involved parties, that are aware of such a legal noncomplinace/fraud  are responsible both legally and morally.

regards


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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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Original Message:
Sent: 25-Oct-2021 19:15
From: Anonymous Member
Subject: Falsely Self-Certified IVDD

This message was posted by a user wishing to remain anonymous

Help! If a company has falsely self-certified its on market products as IVDD and does not have the respective requirements for the Essential Requirements Checklist, such as Quality Management System or other technical documents to support its self declaration and product labeling, what is the risk to the person responsible for the Quality and Regulatory of the company? Who takes the fall if the authorities discover this? Is this a whistleblow opportunity if top management does not take action?

Hmmm good luck.  I would not want to work at a company who, as you said falsely, sells product - disaster wanting to happen.  The answer is: depends on which country would take the legal action according to their local laws and any protection individuals may have under corporate structure.  As example, in the United States thanks to a few companies in the past, the FDA can now prosecute individuals in a company with fines and incarceration.  Also recently with the PIP incident in France, this was also done as well.  And completely agree with Peter definitely a moral issue if the company is knowingly and continues to sell product without maintaining compliance.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 27-Oct-2021 05:24
From: Peter Miko
Subject: Falsely Self-Certified IVDD

Dear Colleague,

I think all involved parties, that are aware of such a legal noncomplinace/fraud  are responsible both legally and morally.

regards


------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary

Original Message:
Sent: 25-Oct-2021 19:15
From: Anonymous Member
Subject: Falsely Self-Certified IVDD

This message was posted by a user wishing to remain anonymous

Help! If a company has falsely self-certified its on market products as IVDD and does not have the respective requirements for the Essential Requirements Checklist, such as Quality Management System or other technical documents to support its self declaration and product labeling, what is the risk to the person responsible for the Quality and Regulatory of the company? Who takes the fall if the authorities discover this? Is this a whistleblow opportunity if top management does not take action?

Couldn't agree more.  I've come accross this In this case of products that are manufactured in the UK and sold accross the UK and the EU, so no FDA involvement.

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Rachel Ryll
Quality Systems Director

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Original Message:
Sent: 27-Oct-2021 07:19
From: Richard Vincins
Subject: Falsely Self-Certified IVDD

Hmmm good luck.  I would not want to work at a company who, as you said falsely, sells product - disaster wanting to happen.  The answer is: depends on which country would take the legal action according to their local laws and any protection individuals may have under corporate structure.  As example, in the United States thanks to a few companies in the past, the FDA can now prosecute individuals in a company with fines and incarceration.  Also recently with the PIP incident in France, this was also done as well.  And completely agree with Peter definitely a moral issue if the company is knowingly and continues to sell product without maintaining compliance.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 27-Oct-2021 05:24
From: Peter Miko
Subject: Falsely Self-Certified IVDD

Dear Colleague,

I think all involved parties, that are aware of such a legal noncomplinace/fraud  are responsible both legally and morally.

regards


------------------------------
Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary

Original Message:
Sent: 25-Oct-2021 19:15
From: Anonymous Member
Subject: Falsely Self-Certified IVDD

This message was posted by a user wishing to remain anonymous

Help! If a company has falsely self-certified its on market products as IVDD and does not have the respective requirements for the Essential Requirements Checklist, such as Quality Management System or other technical documents to support its self declaration and product labeling, what is the risk to the person responsible for the Quality and Regulatory of the company? Who takes the fall if the authorities discover this? Is this a whistleblow opportunity if top management does not take action?

Did they know it was false? If not, then you may be able to educate them, put together a quality plan and sort it all out (perhaps not without a recall though).

If so, then honestly, just get out. Most of the time authorities go for top management, but it isn't completely unheard of for the top RA/QA person to also get entangled in it. Particularly with the countries that require appointment of a "responsible person" there is just too much risk, IMO, to stay at such a company.

If it is not a question of "stay" but being hired to fix things, I'd make sure my contract was written so that I had complete authority over those types of decisions (as well as recalls, safety issues etc)

Ginger

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 25-Oct-2021 19:15
From: Anonymous Member
Subject: Falsely Self-Certified IVDD

This message was posted by a user wishing to remain anonymous

Help! If a company has falsely self-certified its on market products as IVDD and does not have the respective requirements for the Essential Requirements Checklist, such as Quality Management System or other technical documents to support its self declaration and product labeling, what is the risk to the person responsible for the Quality and Regulatory of the company? Who takes the fall if the authorities discover this? Is this a whistleblow opportunity if top management does not take action?

Hi
simply, run away from such a company

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Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
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Original Message:
Sent: 25-Oct-2021 19:15
From: Anonymous Member
Subject: Falsely Self-Certified IVDD

This message was posted by a user wishing to remain anonymous

Help! If a company has falsely self-certified its on market products as IVDD and does not have the respective requirements for the Essential Requirements Checklist, such as Quality Management System or other technical documents to support its self declaration and product labeling, what is the risk to the person responsible for the Quality and Regulatory of the company? Who takes the fall if the authorities discover this? Is this a whistleblow opportunity if top management does not take action?