Regulatory Open Forum

Hello,
I have a question about devices that can be implanted/inserted into the body for a long period of time such as several months or even years. E.g. catheters or PEG-tubes - devices that can be used for feeding or supplying nutrients or medicines for a prolonged period of time.
Our MoH asks for supporting documents that such a tube can stay in a body for a certain period of time that is mentioned in IFU. Manufacturer states in IFU that tubes can be left for as long as 5 years, but at the same time the only report they have is in-vitro testing that supports 1 year period, not 5 years. The manufacturer referred us to some clinical guidelines, but is it sufficient even in EU? What kind of documents are required in EU in order to support such statements in IFU? Any standard?

Thank you!
Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Hello Oksana,

There is not necessarily a standard which talks about use of a device or usability life of a device, not any of the requirements which may be required.  There are some regulations which talk about needing this, there are some guidance documents for specific products which talk about it, but really it is left up to each manufacturer to determine the shelf life, usable life, or lifetime of the device.  Indeed in EU there are expectations the lifetime of the device/usable life of the device is clearly defined and there is supporting technical documentation for this lifetime.  In the scenario where you have a catheter which can be left in as long as 5 years, I do not think in vitro testing that supports 1 year would be sufficient for some regulatory agencies.  Without seeing some of the performance testing and those 'clinical guidelines' it would be hard to say if a 5 year use period would be supported - however this would typically be needed.  We do see the need from Notified Bodies for performance testing supporting the shelf life, usable life, and over the entire life time of the device.

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

Original Message:
Sent: 23-Jun-2021 14:52
From: Oksana Kolosova
Subject: Stability data for implantable devices

Hello,
I have a question about devices that can be implanted/inserted into the body for a long period of time such as several months or even years. E.g. catheters or PEG-tubes - devices that can be used for feeding or supplying nutrients or medicines for a prolonged period of time.
Our MoH asks for supporting documents that such a tube can stay in a body for a certain period of time that is mentioned in IFU. Manufacturer states in IFU that tubes can be left for as long as 5 years, but at the same time the only report they have is in-vitro testing that supports 1 year period, not 5 years. The manufacturer referred us to some clinical guidelines, but is it sufficient even in EU? What kind of documents are required in EU in order to support such statements in IFU? Any standard?

Thank you!
Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Thank you very much, Richard.
It is very helpful as our regional Marketing keeps insisting that they want to see 5 years in IFU just as it is stated in the original IFU. However, Russian MoH often insists on their own interpretation and do not approve IFUs if there is not enough proof to support the data...
I was puzzled how such IFUs are implemented in EU, but if there is no strict guidelines or standard, then the situation is different.

Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 24-Jun-2021 04:25
From: Richard Vincins
Subject: Stability data for implantable devices

Hello Oksana,

There is not necessarily a standard which talks about use of a device or usability life of a device, not any of the requirements which may be required.  There are some regulations which talk about needing this, there are some guidance documents for specific products which talk about it, but really it is left up to each manufacturer to determine the shelf life, usable life, or lifetime of the device.  Indeed in EU there are expectations the lifetime of the device/usable life of the device is clearly defined and there is supporting technical documentation for this lifetime.  In the scenario where you have a catheter which can be left in as long as 5 years, I do not think in vitro testing that supports 1 year would be sufficient for some regulatory agencies.  Without seeing some of the performance testing and those 'clinical guidelines' it would be hard to say if a 5 year use period would be supported - however this would typically be needed.  We do see the need from Notified Bodies for performance testing supporting the shelf life, usable life, and over the entire life time of the device.

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

Original Message:
Sent: 23-Jun-2021 14:52
From: Oksana Kolosova
Subject: Stability data for implantable devices

Hello,
I have a question about devices that can be implanted/inserted into the body for a long period of time such as several months or even years. E.g. catheters or PEG-tubes - devices that can be used for feeding or supplying nutrients or medicines for a prolonged period of time.
Our MoH asks for supporting documents that such a tube can stay in a body for a certain period of time that is mentioned in IFU. Manufacturer states in IFU that tubes can be left for as long as 5 years, but at the same time the only report they have is in-vitro testing that supports 1 year period, not 5 years. The manufacturer referred us to some clinical guidelines, but is it sufficient even in EU? What kind of documents are required in EU in order to support such statements in IFU? Any standard?

Thank you!
Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Dear Oksana,

 my opinion is, that in the time of evidence based medicine, statements like long-term use of invasive  devices and implants are expected to be evidence based. This is a general requirement in all countries, in and beyond Europe. The MDR Art 2. (51) defines what clinical evidence means " clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer".

According to this, what is needed to justify the long term use of the concerned devices are clinical data (MDR Art.2 (48), "information concerning safety or performance that is generated from the use of a device and is sourced from the following: .. clinical investigations, …published reports,.. relevant information from PMS/PMCF" activities.

It is also inevitable, that the design/construction of the medical device and its performance should match the standards of the state-of-the-art of the relevant health care technology.

 I do apologise to say, but I think your question is not about the stability of implantable devices (which is the shelf-life), but the implant survival or length of use in the human body. 

regards

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

Original Message:
Sent: 29-Jun-2021 15:04
From: Oksana Kolosova
Subject: Stability data for implantable devices

Thank you very much, Richard.
It is very helpful as our regional Marketing keeps insisting that they want to see 5 years in IFU just as it is stated in the original IFU. However, Russian MoH often insists on their own interpretation and do not approve IFUs if there is not enough proof to support the data...
I was puzzled how such IFUs are implemented in EU, but if there is no strict guidelines or standard, then the situation is different.

Oksana

------------------------------
Oksana Kolosova
Moscow

Original Message:
Sent: 24-Jun-2021 04:25
From: Richard Vincins
Subject: Stability data for implantable devices

Hello Oksana,

There is not necessarily a standard which talks about use of a device or usability life of a device, not any of the requirements which may be required.  There are some regulations which talk about needing this, there are some guidance documents for specific products which talk about it, but really it is left up to each manufacturer to determine the shelf life, usable life, or lifetime of the device.  Indeed in EU there are expectations the lifetime of the device/usable life of the device is clearly defined and there is supporting technical documentation for this lifetime.  In the scenario where you have a catheter which can be left in as long as 5 years, I do not think in vitro testing that supports 1 year would be sufficient for some regulatory agencies.  Without seeing some of the performance testing and those 'clinical guidelines' it would be hard to say if a 5 year use period would be supported - however this would typically be needed.  We do see the need from Notified Bodies for performance testing supporting the shelf life, usable life, and over the entire life time of the device.

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

Original Message:
Sent: 23-Jun-2021 14:52
From: Oksana Kolosova
Subject: Stability data for implantable devices

Hello,
I have a question about devices that can be implanted/inserted into the body for a long period of time such as several months or even years. E.g. catheters or PEG-tubes - devices that can be used for feeding or supplying nutrients or medicines for a prolonged period of time.
Our MoH asks for supporting documents that such a tube can stay in a body for a certain period of time that is mentioned in IFU. Manufacturer states in IFU that tubes can be left for as long as 5 years, but at the same time the only report they have is in-vitro testing that supports 1 year period, not 5 years. The manufacturer referred us to some clinical guidelines, but is it sufficient even in EU? What kind of documents are required in EU in order to support such statements in IFU? Any standard?

Thank you!
Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Thank you, Peter. That looks logical. However in our case, there are 2 steps of Expertise in Russia and clinical reports etc. are not being reviewed during the first step. I am afraid Russian authorities require in this case some evidence that a device itself won't change or loose any of its abilities to perform the function during the period while it stays in a body. It is probably not a stability, but also there should be something more than just a clinical evidence. 

Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 30-Jun-2021 10:27
From: Peter Miko
Subject: Stability data for implantable devices

Dear Oksana,

 my opinion is, that in the time of evidence based medicine, statements like long-term use of invasive  devices and implants are expected to be evidence based. This is a general requirement in all countries, in and beyond Europe. The MDR Art 2. (51) defines what clinical evidence means " clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer".

According to this, what is needed to justify the long term use of the concerned devices are clinical data (MDR Art.2 (48), "information concerning safety or performance that is generated from the use of a device and is sourced from the following: .. clinical investigations, …published reports,.. relevant information from PMS/PMCF" activities.

It is also inevitable, that the design/construction of the medical device and its performance should match the standards of the state-of-the-art of the relevant health care technology.

 I do apologise to say, but I think your question is not about the stability of implantable devices (which is the shelf-life), but the implant survival or length of use in the human body. 

regards

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

Original Message:
Sent: 29-Jun-2021 15:04
From: Oksana Kolosova
Subject: Stability data for implantable devices

Thank you very much, Richard.
It is very helpful as our regional Marketing keeps insisting that they want to see 5 years in IFU just as it is stated in the original IFU. However, Russian MoH often insists on their own interpretation and do not approve IFUs if there is not enough proof to support the data...
I was puzzled how such IFUs are implemented in EU, but if there is no strict guidelines or standard, then the situation is different.

Oksana

------------------------------
Oksana Kolosova
Moscow

Original Message:
Sent: 24-Jun-2021 04:25
From: Richard Vincins
Subject: Stability data for implantable devices

Hello Oksana,

There is not necessarily a standard which talks about use of a device or usability life of a device, not any of the requirements which may be required.  There are some regulations which talk about needing this, there are some guidance documents for specific products which talk about it, but really it is left up to each manufacturer to determine the shelf life, usable life, or lifetime of the device.  Indeed in EU there are expectations the lifetime of the device/usable life of the device is clearly defined and there is supporting technical documentation for this lifetime.  In the scenario where you have a catheter which can be left in as long as 5 years, I do not think in vitro testing that supports 1 year would be sufficient for some regulatory agencies.  Without seeing some of the performance testing and those 'clinical guidelines' it would be hard to say if a 5 year use period would be supported - however this would typically be needed.  We do see the need from Notified Bodies for performance testing supporting the shelf life, usable life, and over the entire life time of the device.

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

Original Message:
Sent: 23-Jun-2021 14:52
From: Oksana Kolosova
Subject: Stability data for implantable devices

Hello,
I have a question about devices that can be implanted/inserted into the body for a long period of time such as several months or even years. E.g. catheters or PEG-tubes - devices that can be used for feeding or supplying nutrients or medicines for a prolonged period of time.
Our MoH asks for supporting documents that such a tube can stay in a body for a certain period of time that is mentioned in IFU. Manufacturer states in IFU that tubes can be left for as long as 5 years, but at the same time the only report they have is in-vitro testing that supports 1 year period, not 5 years. The manufacturer referred us to some clinical guidelines, but is it sufficient even in EU? What kind of documents are required in EU in order to support such statements in IFU? Any standard?

Thank you!
Oksana

------------------------------
Oksana Kolosova
Moscow
------------------------------