Regulatory Open Forum

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

Hi Elizabeth.

NBOG 2014-3 states:
"A change in the shelf life is considered a substantial change, and an approval by the Notified Body is required, when the protocols and methods for determining shelf life have been changed or have not been reviewed in a previous approval."

Has the NB has already reviewed the protocol and methods used? If yes, the change can be considered non-substantial and managed per your NB contract / internal procedures (e.g., change notification).

If you have revised the protocol to add the new test time points but made no other changes, you could risk a justification to your NB that the change in non-substantial because the methods, acceptance criteria, sample size, storage conditions, etc., are all exactly as described in the protocol that they approved. This is risky because the NB may allow only a strict interpretation of the NBOG language (i.e., change in protocol = substantial change) and require a full certificate amendment submission.

Mark

------------------------------
Mark Mortellaro
Sr. Principal Regulatory Scientist
Clarksburg MD
United States

Original Message:
Sent: 04-May-2023 08:48
From: Elizabeth Bereza
Subject: Shelf Life Extension after MDR Approval

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States
------------------------------

Thanks Mark.  This is some of the same discussion we have been having.  My manager said she actually had someone from the NB tell them the NBOG 2014-3 is old and they shouldn't use it anymore.

There is also the following in MDCG 2020-3: "In principle, an increase in shelf life can be considered non-significant (e.g. the increase is made following the completion of a real time test whose method and end-point was validated and previously assessed by the notified body)"

We were trying to find if there were any other guidances or anything besides those 2 documents.

The protocol has not been reviewed yet.  The idea is to submit with 3 years data to be able to submit sooner and then finish the 5 year testing after submittal.

Thanks for your comments.

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States

Original Message:
Sent: 04-May-2023 10:08
From: Mark Mortellaro
Subject: Shelf Life Extension after MDR Approval

Hi Elizabeth.

NBOG 2014-3 states:
"A change in the shelf life is considered a substantial change, and an approval by the Notified Body is required, when the protocols and methods for determining shelf life have been changed or have not been reviewed in a previous approval."

Has the NB has already reviewed the protocol and methods used? If yes, the change can be considered non-substantial and managed per your NB contract / internal procedures (e.g., change notification).

If you have revised the protocol to add the new test time points but made no other changes, you could risk a justification to your NB that the change in non-substantial because the methods, acceptance criteria, sample size, storage conditions, etc., are all exactly as described in the protocol that they approved. This is risky because the NB may allow only a strict interpretation of the NBOG language (i.e., change in protocol = substantial change) and require a full certificate amendment submission.

Mark

------------------------------
Mark Mortellaro
Sr. Principal Regulatory Scientist
Clarksburg MD
United States

Original Message:
Sent: 04-May-2023 08:48
From: Elizabeth Bereza
Subject: Shelf Life Extension after MDR Approval

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States
------------------------------

NOB 2014-3 is old and should be updated but nonetheless, it is still the applicable guidance for making this decision. I am surprised to hear that an NB stated otherwise. The submission form that our NB requires us to use explicitly cites NBOG 2014-3 for justifying if a change is substantial or not. That form also explicitly cites MDCG 2020-3 as applicable for legacy devices (not for devices approved under the MDR). No other guidances are cited on the NB form.

I  would prefer to use MDCG 2020-3 for MDR changes since it is much clearer than NBOG 2014-3, but the scope is clearly for legacy devices. However, if your NB is pointing you to that guidance, that is great news.

Thanks Mark.  This is some of the same discussion we have been having.  My manager said she actually had someone from the NB tell them the NBOG 2014-3 is old and they shouldn't use it anymore.

There is also the following in MDCG 2020-3: "In principle, an increase in shelf life can be considered non-significant (e.g. the increase is made following the completion of a real time test whose method and end-point was validated and previously assessed by the notified body)"

We were trying to find if there were any other guidances or anything besides those 2 documents.

The protocol has not been reviewed yet.  The idea is to submit with 3 years data to be able to submit sooner and then finish the 5 year testing after submittal.

Thanks for your comments.

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States

Original Message:
Sent: 04-May-2023 10:08
From: Mark Mortellaro
Subject: Shelf Life Extension after MDR Approval

Hi Elizabeth.

NBOG 2014-3 states:
"A change in the shelf life is considered a substantial change, and an approval by the Notified Body is required, when the protocols and methods for determining shelf life have been changed or have not been reviewed in a previous approval."

Has the NB has already reviewed the protocol and methods used? If yes, the change can be considered non-substantial and managed per your NB contract / internal procedures (e.g., change notification).

If you have revised the protocol to add the new test time points but made no other changes, you could risk a justification to your NB that the change in non-substantial because the methods, acceptance criteria, sample size, storage conditions, etc., are all exactly as described in the protocol that they approved. This is risky because the NB may allow only a strict interpretation of the NBOG language (i.e., change in protocol = substantial change) and require a full certificate amendment submission.

Mark

------------------------------
Mark Mortellaro
Sr. Principal Regulatory Scientist
Clarksburg MD
United States

Original Message:
Sent: 04-May-2023 08:48
From: Elizabeth Bereza
Subject: Shelf Life Extension after MDR Approval

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States
------------------------------

Hello Liz,

NBOG 2014-3 is the old one and while it is helpful guidance, it is for the EU MDD, so should not really be used for the EU MDR (though people still do use it, even Notified Bodies).  The more recent one is the MDCG 2020-3 which is for EU MDD devices, but I know many are using for EU MDR purposes as well.  Hopefully at some point they will either update MDCG 2020-3 or have a new MDCG which is aligned with the NBOG document which describes "significant changes" under EU MDR.  There is much interpretation around significant change, and in your example it most likely would be considered a significant change.  I do not think the MDCG 2020-3 is quite clear in this regard.  Your Notified Body ultimately has the decision, so you should discuss it with them ... before you make the change as well.

NOB 2014-3 is old and should be updated but nonetheless, it is still the applicable guidance for making this decision. I am surprised to hear that an NB stated otherwise. The submission form that our NB requires us to use explicitly cites NBOG 2014-3 for justifying if a change is substantial or not. That form also explicitly cites MDCG 2020-3 as applicable for legacy devices (not for devices approved under the MDR). No other guidances are cited on the NB form.

I  would prefer to use MDCG 2020-3 for MDR changes since it is much clearer than NBOG 2014-3, but the scope is clearly for legacy devices. However, if your NB is pointing you to that guidance, that is great news.

Thanks Mark.  This is some of the same discussion we have been having.  My manager said she actually had someone from the NB tell them the NBOG 2014-3 is old and they shouldn't use it anymore.

There is also the following in MDCG 2020-3: "In principle, an increase in shelf life can be considered non-significant (e.g. the increase is made following the completion of a real time test whose method and end-point was validated and previously assessed by the notified body)"

We were trying to find if there were any other guidances or anything besides those 2 documents.

The protocol has not been reviewed yet.  The idea is to submit with 3 years data to be able to submit sooner and then finish the 5 year testing after submittal.

Thanks for your comments.

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States

Original Message:
Sent: 04-May-2023 10:08
From: Mark Mortellaro
Subject: Shelf Life Extension after MDR Approval

Hi Elizabeth.

NBOG 2014-3 states:
"A change in the shelf life is considered a substantial change, and an approval by the Notified Body is required, when the protocols and methods for determining shelf life have been changed or have not been reviewed in a previous approval."

Has the NB has already reviewed the protocol and methods used? If yes, the change can be considered non-substantial and managed per your NB contract / internal procedures (e.g., change notification).

If you have revised the protocol to add the new test time points but made no other changes, you could risk a justification to your NB that the change in non-substantial because the methods, acceptance criteria, sample size, storage conditions, etc., are all exactly as described in the protocol that they approved. This is risky because the NB may allow only a strict interpretation of the NBOG language (i.e., change in protocol = substantial change) and require a full certificate amendment submission.

Mark

------------------------------
Mark Mortellaro
Sr. Principal Regulatory Scientist
Clarksburg MD
United States

Original Message:
Sent: 04-May-2023 08:48
From: Elizabeth Bereza
Subject: Shelf Life Extension after MDR Approval

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States
------------------------------

Thanks Richard.  There is a change notification form that the NB uses where we can state our position and let them decide if they agree with it.  I have suggested this to my manager.

Hello Liz,

NBOG 2014-3 is the old one and while it is helpful guidance, it is for the EU MDD, so should not really be used for the EU MDR (though people still do use it, even Notified Bodies).  The more recent one is the MDCG 2020-3 which is for EU MDD devices, but I know many are using for EU MDR purposes as well.  Hopefully at some point they will either update MDCG 2020-3 or have a new MDCG which is aligned with the NBOG document which describes "significant changes" under EU MDR.  There is much interpretation around significant change, and in your example it most likely would be considered a significant change.  I do not think the MDCG 2020-3 is quite clear in this regard.  Your Notified Body ultimately has the decision, so you should discuss it with them ... before you make the change as well.

NOB 2014-3 is old and should be updated but nonetheless, it is still the applicable guidance for making this decision. I am surprised to hear that an NB stated otherwise. The submission form that our NB requires us to use explicitly cites NBOG 2014-3 for justifying if a change is substantial or not. That form also explicitly cites MDCG 2020-3 as applicable for legacy devices (not for devices approved under the MDR). No other guidances are cited on the NB form.

I  would prefer to use MDCG 2020-3 for MDR changes since it is much clearer than NBOG 2014-3, but the scope is clearly for legacy devices. However, if your NB is pointing you to that guidance, that is great news.

Thanks Mark.  This is some of the same discussion we have been having.  My manager said she actually had someone from the NB tell them the NBOG 2014-3 is old and they shouldn't use it anymore.

There is also the following in MDCG 2020-3: "In principle, an increase in shelf life can be considered non-significant (e.g. the increase is made following the completion of a real time test whose method and end-point was validated and previously assessed by the notified body)"

We were trying to find if there were any other guidances or anything besides those 2 documents.

The protocol has not been reviewed yet.  The idea is to submit with 3 years data to be able to submit sooner and then finish the 5 year testing after submittal.

Thanks for your comments.

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States

Original Message:
Sent: 04-May-2023 10:08
From: Mark Mortellaro
Subject: Shelf Life Extension after MDR Approval

Hi Elizabeth.

NBOG 2014-3 states:
"A change in the shelf life is considered a substantial change, and an approval by the Notified Body is required, when the protocols and methods for determining shelf life have been changed or have not been reviewed in a previous approval."

Has the NB has already reviewed the protocol and methods used? If yes, the change can be considered non-substantial and managed per your NB contract / internal procedures (e.g., change notification).

If you have revised the protocol to add the new test time points but made no other changes, you could risk a justification to your NB that the change in non-substantial because the methods, acceptance criteria, sample size, storage conditions, etc., are all exactly as described in the protocol that they approved. This is risky because the NB may allow only a strict interpretation of the NBOG language (i.e., change in protocol = substantial change) and require a full certificate amendment submission.

Mark

------------------------------
Mark Mortellaro
Sr. Principal Regulatory Scientist
Clarksburg MD
United States

Original Message:
Sent: 04-May-2023 08:48
From: Elizabeth Bereza
Subject: Shelf Life Extension after MDR Approval

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States
------------------------------

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

Apart from the other comments regarding the notified body, there is also UDI to take into account. As far as I see this would trigger a new UDI-DI, but the device can remain under the same Basic UDI-DI.

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 04-May-2023 08:48
From: Elizabeth Bereza
Subject: Shelf Life Extension after MDR Approval

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States
------------------------------

Ronald,

I don't see why this would trigger a new UDI.  The only thing changing would be the expiration date.  MDCG 2022-7 says the following:

"A new UDI-DI assignment is required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability.
In particular, a new UDI-DI (created in compliance with the rules of the designated issuing entities), is required in the case of any change of the following elements:
 name or trade name,
 device version or model,
 labelled as single use,
 packaged sterile,
 need for sterilization before use,
 quantity of devices provided in a package,
 critical warnings or contra-indications (e.g. Containing latex or DEHP), CMR/Endocrine disruptors"

I don't believe extending the shelf life would apply.  If you have other info please pass it along.  Thank you.

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States

Original Message:
Sent: 09-May-2023 01:37
From: Ronald Boumans
Subject: Shelf Life Extension after MDR Approval

Apart from the other comments regarding the notified body, there is also UDI to take into account. As far as I see this would trigger a new UDI-DI, but the device can remain under the same Basic UDI-DI.

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 04-May-2023 08:48
From: Elizabeth Bereza
Subject: Shelf Life Extension after MDR Approval

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!

------------------------------
Liz Bereza, MSRA, RAC-Devices, CMDA
Senior Regulatory Affairs Specialist
Raleigh NC United States
------------------------------

Let's say you submit your intial MDR technical documentation with testing completed for 3 years accelerated aging.  Subsequently you complete 5 years of accelerated aging and want to increase the shelf life.  What would be the required filing or notification for this change?  A letter to file, a change notification, a new filing?

There have been some disagreements on this in my workplace and I am trying to find concrete info.  Any information anyone can point me to would be super helpful.

Thanks in advance!