Regulatory Open Forum

Hello! 

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class. 

My question: how are you all complying to this one? 

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage? 

TIA! 
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Hello Stephanie,

I would also be interested to hear how companies are implementing this requirement within their quality system.

From my perspective auditing to EU IVDR (and EU MDR) we do need to verify compliance with this requirement.  Typically there is a reference contained in the Quality Manual or the Strategy for Regulatory Compliance (also something required in the Obligations of the Manufacturer).  This reference to liability insurance is usually to legal or administrative department who could provide a current copy of the company liability insurance - kept in legal or administration with other contracts or business related items.  I personally would not necessarily see the liability insurance as part of the quality system, i.e. assigned a document identification, though it would be good practice.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Thank you for your reply. This is very helpful. I like the idea of mentioning it in the Quality Manual at a minimum.

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Original Message:
Sent: 02-Sep-2022 03:26
From: Richard Vincins
Subject: IVDR Requirement for Liability Insurance

Hello Stephanie,

I would also be interested to hear how companies are implementing this requirement within their quality system.

From my perspective auditing to EU IVDR (and EU MDR) we do need to verify compliance with this requirement.  Typically there is a reference contained in the Quality Manual or the Strategy for Regulatory Compliance (also something required in the Obligations of the Manufacturer).  This reference to liability insurance is usually to legal or administrative department who could provide a current copy of the company liability insurance - kept in legal or administration with other contracts or business related items.  I personally would not necessarily see the liability insurance as part of the quality system, i.e. assigned a document identification, though it would be good practice.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Stephanie

It will just be your corporate business insurance policy.   Make sure will your CEO  that the expect liability limits are covered to include EU.

Why put that in an SOP? 

Ginger 


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

Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Thank you for your reply. We don't have a corporate insurance policy within our QMS. I'm assuming that would need to be brought into the QMS.

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Original Message:
Sent: 02-Sep-2022 08:22
From: Ginger Cantor
Subject: IVDR Requirement for Liability Insurance

Stephanie

It will just be your corporate business insurance policy.   Make sure will your CEO  that the expect liability limits are covered to include EU.

Why put that in an SOP?

Ginger


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

Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

This message was posted by a user wishing to remain anonymous

From my experience at a past job role, the Legal department verified the company's insurance policy had the financial coverage for potential liability per the device's risk class, meeting the IVDR requirement. It depends on the company's processes and QMS but this could be added to applicable IVDR documentation, referencing where the policy document(s) are kept and any other relevant information regarding the insurance coverage. RA having a copy of the insurance policy would be helpful for audits incase this article's requirement is audited.
Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

This message was posted by a user wishing to remain anonymous

If you're outside the Union, you'll probably need to provide evidence of coverage to your EC REP.
Original Message:
Sent: 01-Sep-2022 22:54
From: Anonymous Member
Subject: IVDR Requirement for Liability Insurance

This message was posted by a user wishing to remain anonymous

From my experience at a past job role, the Legal department verified the company's insurance policy had the financial coverage for potential liability per the device's risk class, meeting the IVDR requirement. It depends on the company's processes and QMS but this could be added to applicable IVDR documentation, referencing where the policy document(s) are kept and any other relevant information regarding the insurance coverage. RA having a copy of the insurance policy would be helpful for audits incase this article's requirement is audited.
Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

In my experience notified bodies audit manufacturers on their choices in relation to implementation of this requirement, so you'll need to have rationale ready why the cover chosen was opted for, and on what basis. For example, one notified body required an insurance cover that covered 'worse case scenario' for the devices in scope without explaining what they consider liability worse case scenario (which logical, because notified bodies are not lawyers). In the end, the notified body accepted a rationale based on extrapolation of historical vigilance data for the devices concerned overlayed with historical liability claims data, which showed that the company's insurance cover could accomodate a factor 100 increase in liaiblity cases and still suffice.
So you'll have to be able to explain how you've applied the mystical formula of size of the company, type of device (defined nowhere in the IVDR by the way so good luck) and risk class.
However, things have also changed with product liability in the Union with 
1) update of the EU product liability directive pending that stands to change a lot, especially regarding software and online services; and
2) the collective redress directive having been implemented in national law everywhere, resulting in the option of class actions for (explicitly mentioned in the annex of the directive) medical devices and IVDs.
The issues I've seen companies struggle with is that the legal department does not understand this requirement or what a notified body could expect here (because regulatory) and the regulatory department does not understand liability and interprets the requirement wrong. And then we have notified bodies that are also feeling their way along for a lack of guidance, and have to answer to competent authorities that also don't understand liability (because that's not what their competent for).
So yes, it's a process, and yes you need to spend some time with data to construct good rationale to show that your cover will suffice in the scenarios the notified body wants to see (if any).

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

Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Wow, thank you for your very thorough reply. Very helpful!

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------

Original Message:
Sent: 03-Sep-2022 03:37
From: Erik Vollebregt
Subject: IVDR Requirement for Liability Insurance

In my experience notified bodies audit manufacturers on their choices in relation to implementation of this requirement, so you'll need to have rationale ready why the cover chosen was opted for, and on what basis. For example, one notified body required an insurance cover that covered 'worse case scenario' for the devices in scope without explaining what they consider liability worse case scenario (which logical, because notified bodies are not lawyers). In the end, the notified body accepted a rationale based on extrapolation of historical vigilance data for the devices concerned overlayed with historical liability claims data, which showed that the company's insurance cover could accomodate a factor 100 increase in liaiblity cases and still suffice.
So you'll have to be able to explain how you've applied the mystical formula of size of the company, type of device (defined nowhere in the IVDR by the way so good luck) and risk class.
However, things have also changed with product liability in the Union with
1) update of the EU product liability directive pending that stands to change a lot, especially regarding software and online services; and
2) the collective redress directive having been implemented in national law everywhere, resulting in the option of class actions for (explicitly mentioned in the annex of the directive) medical devices and IVDs.
The issues I've seen companies struggle with is that the legal department does not understand this requirement or what a notified body could expect here (because regulatory) and the regulatory department does not understand liability and interprets the requirement wrong. And then we have notified bodies that are also feeling their way along for a lack of guidance, and have to answer to competent authorities that also don't understand liability (because that's not what their competent for).
So yes, it's a process, and yes you need to spend some time with data to construct good rationale to show that your cover will suffice in the scenarios the notified body wants to see (if any).

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

Original Message:
Sent: 01-Sep-2022 14:31
From: Stephanie Mantooth
Subject: IVDR Requirement for Liability Insurance

Hello!

Item 15 of Article 10 of the IVDR states that a company must have in place measures to provide sufficient financial coverage in respect of their potential liability proportionate to the risk class.

My question: how are you all complying to this one?

Did you create a stand-alone process (eg SOP or form) to proceduralize this? Did you add it to your risk documentation as a check box item basically saying you have verified insurance coverage?

TIA!
Steph

------------------------------
Stephanie Mantooth
RA Specialist
Austin TX
United States
------------------------------