Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance. 

Thank you!

Anon

Good day Anon,

Ohhhh very interesting question.  There is certainly some thoughts I have and others may have, but honestly you should have this discussion with your Notified Body.  From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union.  During this transition period, if you are using your own device, with a CE MDD certificate, does it need to go to EU MDR?  I would think if you clearly document in the Technical Documentation the end of life for the previous generation, show the comparison, and how the new generation device is the same (or better), that might be sufficient - meaning no it should not have to be CE Marked under the EU MDR.  Also what I might recommend is if there has already been an overlapping period of time showing the clinical evidence of your current generation device as compared to the previous generation, why still keep claiming equivalence?  If you can show your current version of the device has sufficient clinical evidence, then you do not need to have an equivalent device.  Remember, clinical evaluation is not about 'x' number of clinical literature, 'x' years of product being on the market, having an equivalent device, or even having 10 clinical studies performed.  The main point of clinical evaluation is supporting the device safety and performance through sufficient clinical evidence.  Sadly, many Notified Body reviewers miss this point.  It is not about having a 100 page clinical evaluation report or having hundreds of clinical literature articles.  If I have a well established product on the market with many years of real world data - post market data - then I just need to show there is sufficient evidence my device is safe and performs as intended.  What reviewers miss is all the connection between clinical evaluation, post market data, and risk management supporting a device is safe and performs.  I just have to shake my head seeing the types of non-conformity statements on products which have been sold around the world for 20 years, and yet now under EU CE Marking the device safety and performance is being called into question as there is some earth-shattering revelation they find missing in a clinical evaluation report.  I would also recommend reading through (a few times, usually needed) the MDCG guidance documents like MDCG 2020-5 and -6 also reading the latest IMDRF guidance on clinical evaluation.

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

Original Message:
Sent: 24-Feb-2021 11:53
From: Anonymous Member
Subject: CE Certificate active for equivalent device

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance.

Thank you!

Anon

"From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union."

A side question: does a predicate device for submission to the FDA have to be legally marketed in the US? Or a CE marked device would suffice? And does the device still have to be on the market?

------------------------------
AnaCiric
RA/QA Specialist
Singapore
------------------------------

Original Message:
Sent: 25-Feb-2021 04:34
From: Richard Vincins
Subject: CE Certificate active for equivalent device

Good day Anon,

Ohhhh very interesting question.  There is certainly some thoughts I have and others may have, but honestly you should have this discussion with your Notified Body.  From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union.  During this transition period, if you are using your own device, with a CE MDD certificate, does it need to go to EU MDR?  I would think if you clearly document in the Technical Documentation the end of life for the previous generation, show the comparison, and how the new generation device is the same (or better), that might be sufficient - meaning no it should not have to be CE Marked under the EU MDR.  Also what I might recommend is if there has already been an overlapping period of time showing the clinical evidence of your current generation device as compared to the previous generation, why still keep claiming equivalence?  If you can show your current version of the device has sufficient clinical evidence, then you do not need to have an equivalent device.  Remember, clinical evaluation is not about 'x' number of clinical literature, 'x' years of product being on the market, having an equivalent device, or even having 10 clinical studies performed.  The main point of clinical evaluation is supporting the device safety and performance through sufficient clinical evidence.  Sadly, many Notified Body reviewers miss this point.  It is not about having a 100 page clinical evaluation report or having hundreds of clinical literature articles.  If I have a well established product on the market with many years of real world data - post market data - then I just need to show there is sufficient evidence my device is safe and performs as intended.  What reviewers miss is all the connection between clinical evaluation, post market data, and risk management supporting a device is safe and performs.  I just have to shake my head seeing the types of non-conformity statements on products which have been sold around the world for 20 years, and yet now under EU CE Marking the device safety and performance is being called into question as there is some earth-shattering revelation they find missing in a clinical evaluation report.  I would also recommend reading through (a few times, usually needed) the MDCG guidance documents like MDCG 2020-5 and -6 also reading the latest IMDRF guidance on clinical evaluation.

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

Original Message:
Sent: 24-Feb-2021 11:53
From: Anonymous Member
Subject: CE Certificate active for equivalent device

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance.

Thank you!

Anon

Interestingly when I have submitted 510(k) submissions in the past, even on a couple occasions a predicate device we knew was no longer on the market.  This was not questioned, because according to the FDA's substantial equivalence process just need to reference the 510(k).  There was no need (or requirement) to show the device is still legally marketed in the US.  Even more frustrating is trying to claim substantial equivalence to a current device on the market with features and intended use, which is not reflected in the original 510(k) from a few years back.  FDA would not accept because these "intended use" were not in the original 510(k) submission.  We would have thought in these cases when we raised this to the FDA, hopefully they might have asked the other company some questions about their claims, intended use, and what was cleared in the original 510(k).  Maybe.

No, you can not use a CE Marked device for FDA substantial equivalence and vice versa.  We have been challenged by Notified Body reviewers in the past about an equivalent device being on the market, which the only way we could show this was an IFU (containing the CE Mark).  In the future, once EUDAMED is fully functional, this should be easier as registered device can be searched on the EUDAMED database.

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

Original Message:
Sent: 03-Mar-2021 20:38
From: Ana Ciric
Subject: CE Certificate active for equivalent device

"From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union."

A side question: does a predicate device for submission to the FDA have to be legally marketed in the US? Or a CE marked device would suffice? And does the device still have to be on the market?

------------------------------
AnaCiric
RA/QA Specialist
Singapore

Original Message:
Sent: 25-Feb-2021 04:34
From: Richard Vincins
Subject: CE Certificate active for equivalent device

Good day Anon,

Ohhhh very interesting question.  There is certainly some thoughts I have and others may have, but honestly you should have this discussion with your Notified Body.  From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union.  During this transition period, if you are using your own device, with a CE MDD certificate, does it need to go to EU MDR?  I would think if you clearly document in the Technical Documentation the end of life for the previous generation, show the comparison, and how the new generation device is the same (or better), that might be sufficient - meaning no it should not have to be CE Marked under the EU MDR.  Also what I might recommend is if there has already been an overlapping period of time showing the clinical evidence of your current generation device as compared to the previous generation, why still keep claiming equivalence?  If you can show your current version of the device has sufficient clinical evidence, then you do not need to have an equivalent device.  Remember, clinical evaluation is not about 'x' number of clinical literature, 'x' years of product being on the market, having an equivalent device, or even having 10 clinical studies performed.  The main point of clinical evaluation is supporting the device safety and performance through sufficient clinical evidence.  Sadly, many Notified Body reviewers miss this point.  It is not about having a 100 page clinical evaluation report or having hundreds of clinical literature articles.  If I have a well established product on the market with many years of real world data - post market data - then I just need to show there is sufficient evidence my device is safe and performs as intended.  What reviewers miss is all the connection between clinical evaluation, post market data, and risk management supporting a device is safe and performs.  I just have to shake my head seeing the types of non-conformity statements on products which have been sold around the world for 20 years, and yet now under EU CE Marking the device safety and performance is being called into question as there is some earth-shattering revelation they find missing in a clinical evaluation report.  I would also recommend reading through (a few times, usually needed) the MDCG guidance documents like MDCG 2020-5 and -6 also reading the latest IMDRF guidance on clinical evaluation.

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

Original Message:
Sent: 24-Feb-2021 11:53
From: Anonymous Member
Subject: CE Certificate active for equivalent device

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance.

Thank you!

Anon

Hi Ana

Yes, the device should be currently marketed. Also FDA really prefers predicates that have been cleared in the past 5-10 years (more data in their files to compare against). Also, if you have more than one suitable predicate, pick the closest in intended use, indications for use and features AND watch out to check if the predicate has been subject to many medical  device reports  (MDR) or recalls.  Especially not a good idea to compare yourself to a device withdrawn from the market because of safety issues 🙄

Good luck!

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

Original Message:
Sent: 03-Mar-2021 20:38
From: Ana Ciric
Subject: CE Certificate active for equivalent device

"From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union."

A side question: does a predicate device for submission to the FDA have to be legally marketed in the US? Or a CE marked device would suffice? And does the device still have to be on the market?

------------------------------
AnaCiric
RA/QA Specialist
Singapore

Original Message:
Sent: 25-Feb-2021 04:34
From: Richard Vincins
Subject: CE Certificate active for equivalent device

Good day Anon,

Ohhhh very interesting question.  There is certainly some thoughts I have and others may have, but honestly you should have this discussion with your Notified Body.  From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union.  During this transition period, if you are using your own device, with a CE MDD certificate, does it need to go to EU MDR?  I would think if you clearly document in the Technical Documentation the end of life for the previous generation, show the comparison, and how the new generation device is the same (or better), that might be sufficient - meaning no it should not have to be CE Marked under the EU MDR.  Also what I might recommend is if there has already been an overlapping period of time showing the clinical evidence of your current generation device as compared to the previous generation, why still keep claiming equivalence?  If you can show your current version of the device has sufficient clinical evidence, then you do not need to have an equivalent device.  Remember, clinical evaluation is not about 'x' number of clinical literature, 'x' years of product being on the market, having an equivalent device, or even having 10 clinical studies performed.  The main point of clinical evaluation is supporting the device safety and performance through sufficient clinical evidence.  Sadly, many Notified Body reviewers miss this point.  It is not about having a 100 page clinical evaluation report or having hundreds of clinical literature articles.  If I have a well established product on the market with many years of real world data - post market data - then I just need to show there is sufficient evidence my device is safe and performs as intended.  What reviewers miss is all the connection between clinical evaluation, post market data, and risk management supporting a device is safe and performs.  I just have to shake my head seeing the types of non-conformity statements on products which have been sold around the world for 20 years, and yet now under EU CE Marking the device safety and performance is being called into question as there is some earth-shattering revelation they find missing in a clinical evaluation report.  I would also recommend reading through (a few times, usually needed) the MDCG guidance documents like MDCG 2020-5 and -6 also reading the latest IMDRF guidance on clinical evaluation.

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

Original Message:
Sent: 24-Feb-2021 11:53
From: Anonymous Member
Subject: CE Certificate active for equivalent device

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance.

Thank you!

Anon

Thank you both Richard and Ginger for your valuable responses.

------------------------------
AnaCiric
RA/QA Specialist
Singapore
------------------------------

Original Message:
Sent: 04-Mar-2021 08:39
From: Ginger Cantor
Subject: CE Certificate active for equivalent device

Hi Ana

Yes, the device should be currently marketed. Also FDA really prefers predicates that have been cleared in the past 5-10 years (more data in their files to compare against). Also, if you have more than one suitable predicate, pick the closest in intended use, indications for use and features AND watch out to check if the predicate has been subject to many medical  device reports  (MDR) or recalls.  Especially not a good idea to compare yourself to a device withdrawn from the market because of safety issues 🙄

Good luck!

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

Original Message:
Sent: 03-Mar-2021 20:38
From: Ana Ciric
Subject: CE Certificate active for equivalent device

"From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union."

A side question: does a predicate device for submission to the FDA have to be legally marketed in the US? Or a CE marked device would suffice? And does the device still have to be on the market?

------------------------------
AnaCiric
RA/QA Specialist
Singapore

Original Message:
Sent: 25-Feb-2021 04:34
From: Richard Vincins
Subject: CE Certificate active for equivalent device

Good day Anon,

Ohhhh very interesting question.  There is certainly some thoughts I have and others may have, but honestly you should have this discussion with your Notified Body.  From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union.  During this transition period, if you are using your own device, with a CE MDD certificate, does it need to go to EU MDR?  I would think if you clearly document in the Technical Documentation the end of life for the previous generation, show the comparison, and how the new generation device is the same (or better), that might be sufficient - meaning no it should not have to be CE Marked under the EU MDR.  Also what I might recommend is if there has already been an overlapping period of time showing the clinical evidence of your current generation device as compared to the previous generation, why still keep claiming equivalence?  If you can show your current version of the device has sufficient clinical evidence, then you do not need to have an equivalent device.  Remember, clinical evaluation is not about 'x' number of clinical literature, 'x' years of product being on the market, having an equivalent device, or even having 10 clinical studies performed.  The main point of clinical evaluation is supporting the device safety and performance through sufficient clinical evidence.  Sadly, many Notified Body reviewers miss this point.  It is not about having a 100 page clinical evaluation report or having hundreds of clinical literature articles.  If I have a well established product on the market with many years of real world data - post market data - then I just need to show there is sufficient evidence my device is safe and performs as intended.  What reviewers miss is all the connection between clinical evaluation, post market data, and risk management supporting a device is safe and performs.  I just have to shake my head seeing the types of non-conformity statements on products which have been sold around the world for 20 years, and yet now under EU CE Marking the device safety and performance is being called into question as there is some earth-shattering revelation they find missing in a clinical evaluation report.  I would also recommend reading through (a few times, usually needed) the MDCG guidance documents like MDCG 2020-5 and -6 also reading the latest IMDRF guidance on clinical evaluation.

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

Original Message:
Sent: 24-Feb-2021 11:53
From: Anonymous Member
Subject: CE Certificate active for equivalent device

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance.

Thank you!

Anon

To add on to Ginger's point, I know former FDA Commissioner Scott Gottlieb suggested limiting predicate devices to those cleared within the last 10 years.

His statement from November 2018 (from FDA website):

"Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks. In some cases, the predicate could be decades old. Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that's more than 10 years old. That doesn't mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

We believe that newer devices should be compared to the benefits and risks of more modern technology; that is why we're looking at ways to promote the use of more recent predicates."

Not sure if there's been any update to this since that time. But I guess a good rule of thumb is just stick to <10 years for your predicate.

------------------------------
Lawrence Maddela
Regulatory Affairs Specialist
Irvine CA
United States
------------------------------

Original Message:
Sent: 04-Mar-2021 08:39
From: Ginger Cantor
Subject: CE Certificate active for equivalent device

Hi Ana

Yes, the device should be currently marketed. Also FDA really prefers predicates that have been cleared in the past 5-10 years (more data in their files to compare against). Also, if you have more than one suitable predicate, pick the closest in intended use, indications for use and features AND watch out to check if the predicate has been subject to many medical  device reports  (MDR) or recalls.  Especially not a good idea to compare yourself to a device withdrawn from the market because of safety issues 🙄

Good luck!

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

Original Message:
Sent: 03-Mar-2021 20:38
From: Ana Ciric
Subject: CE Certificate active for equivalent device

"From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union."

A side question: does a predicate device for submission to the FDA have to be legally marketed in the US? Or a CE marked device would suffice? And does the device still have to be on the market?

------------------------------
AnaCiric
RA/QA Specialist
Singapore

Original Message:
Sent: 25-Feb-2021 04:34
From: Richard Vincins
Subject: CE Certificate active for equivalent device

Good day Anon,

Ohhhh very interesting question.  There is certainly some thoughts I have and others may have, but honestly you should have this discussion with your Notified Body.  From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union.  During this transition period, if you are using your own device, with a CE MDD certificate, does it need to go to EU MDR?  I would think if you clearly document in the Technical Documentation the end of life for the previous generation, show the comparison, and how the new generation device is the same (or better), that might be sufficient - meaning no it should not have to be CE Marked under the EU MDR.  Also what I might recommend is if there has already been an overlapping period of time showing the clinical evidence of your current generation device as compared to the previous generation, why still keep claiming equivalence?  If you can show your current version of the device has sufficient clinical evidence, then you do not need to have an equivalent device.  Remember, clinical evaluation is not about 'x' number of clinical literature, 'x' years of product being on the market, having an equivalent device, or even having 10 clinical studies performed.  The main point of clinical evaluation is supporting the device safety and performance through sufficient clinical evidence.  Sadly, many Notified Body reviewers miss this point.  It is not about having a 100 page clinical evaluation report or having hundreds of clinical literature articles.  If I have a well established product on the market with many years of real world data - post market data - then I just need to show there is sufficient evidence my device is safe and performs as intended.  What reviewers miss is all the connection between clinical evaluation, post market data, and risk management supporting a device is safe and performs.  I just have to shake my head seeing the types of non-conformity statements on products which have been sold around the world for 20 years, and yet now under EU CE Marking the device safety and performance is being called into question as there is some earth-shattering revelation they find missing in a clinical evaluation report.  I would also recommend reading through (a few times, usually needed) the MDCG guidance documents like MDCG 2020-5 and -6 also reading the latest IMDRF guidance on clinical evaluation.

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

Original Message:
Sent: 24-Feb-2021 11:53
From: Anonymous Member
Subject: CE Certificate active for equivalent device

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance.

Thank you!

Anon

This message was posted by a user wishing to remain anonymous

"From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union."

A side question: does a predicate device for submission to the FDA have to be legally marketed in the US? Or a CE marked device would suffice? And does the device still have to be on the market?
Original Message:
Sent: 25-Feb-2021 04:34
From: Richard Vincins
Subject: CE Certificate active for equivalent device

Good day Anon,

Ohhhh very interesting question.  There is certainly some thoughts I have and others may have, but honestly you should have this discussion with your Notified Body.  From my understanding, if you are claiming equivalency for clinical evaluation, the equivalent device needs to be legally marketed in the European Union.  During this transition period, if you are using your own device, with a CE MDD certificate, does it need to go to EU MDR?  I would think if you clearly document in the Technical Documentation the end of life for the previous generation, show the comparison, and how the new generation device is the same (or better), that might be sufficient - meaning no it should not have to be CE Marked under the EU MDR.  Also what I might recommend is if there has already been an overlapping period of time showing the clinical evidence of your current generation device as compared to the previous generation, why still keep claiming equivalence?  If you can show your current version of the device has sufficient clinical evidence, then you do not need to have an equivalent device.  Remember, clinical evaluation is not about 'x' number of clinical literature, 'x' years of product being on the market, having an equivalent device, or even having 10 clinical studies performed.  The main point of clinical evaluation is supporting the device safety and performance through sufficient clinical evidence.  Sadly, many Notified Body reviewers miss this point.  It is not about having a 100 page clinical evaluation report or having hundreds of clinical literature articles.  If I have a well established product on the market with many years of real world data - post market data - then I just need to show there is sufficient evidence my device is safe and performs as intended.  What reviewers miss is all the connection between clinical evaluation, post market data, and risk management supporting a device is safe and performs.  I just have to shake my head seeing the types of non-conformity statements on products which have been sold around the world for 20 years, and yet now under EU CE Marking the device safety and performance is being called into question as there is some earth-shattering revelation they find missing in a clinical evaluation report.  I would also recommend reading through (a few times, usually needed) the MDCG guidance documents like MDCG 2020-5 and -6 also reading the latest IMDRF guidance on clinical evaluation.

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

Original Message:
Sent: 24-Feb-2021 11:53
From: Anonymous Member
Subject: CE Certificate active for equivalent device

This message was posted by a user wishing to remain anonymous

Hello,

I have TD under review by a notified body. The device is class IIa and we are leveraging the prior generation of the device (CE marked) as the equivalent device. We are planning end of life for the equivalent device. Does the equivalent device CE Cert need to be active until an MDR Cert is issued for the device under evaluation? or does that not matter since I am leveraging literature articles on the equivalent device to substantiate safety and performance.

Thank you!

Anon