Regulatory Open Forum

Hello All, 

I've been working on the MDCG 2020-5 Clinical Evaluation - Equivalence in an attempt to find an appropriate work around about with respect to MDR, Annex XIV Part A(3) : Biological Characteristics : 
" the device uses the SAME materials... in contact with the same human tissues...."

This is for a new device going to market for the first time under MDR, class IIa.

The intention is to establish "equivalence" and not "similar" with a device followed by appropriate literature support, so :  
- both devices are in contact with the skin (intact)
- both devices are in contact with the same human tissues
- both devices are "for a similar kind & duration" of contact..

The patient contact is silicon for our device, obviously we now the exact details, etc etc.
However, the sticking point is that we don't know what the "equivalent" device contact material is, we suspect its silicon...  it looks a feels its, unfortunately it is not mentioned anywhere in the technical details available for their device... 
So, the only "common aspect" we can be certain of it that both our device and the "equivalent" device are conform to ISO10993-1, -5, -10. 
I strongly believe that we can demonstrate that silicon is a well established material, in the medical field & such use cannot have an impact on "safety & clinical performance". 

I have yet to approach our Notified Body about this, but I wonder how anyone else have managed this... As I can believe there is going to be a major problem for many devices trying to push through the Clinical Evaluation using "equivalent" device.... but not having proof of the "same materials". 

Any experience anyone ? 

Thanks 
Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal
Aix-en-Provence
France
------------------------------

Hello Tim,

Immediate comment is try not to use equivalency if at all possible.  There is so much mis-understanding of this topic by Notified Bodies even with the release of MDCG 2020-5 - it is challenging approach to use for clinical evaluation process.  In your example, I would agree providing this would show support of the materials being similar.  Unfortunately, under equivalency currently the expectations (and requirement) is you know the exact material of the equivalent device.  So unless they publish this in a public document like their IFU posted on the website, it is virtually impossible to meet this currently or you call up your competitor saying, "Hey, can you provide me some info?" haha  Now, maybe you will have luck with your Notified Body, but 'proof of same materials' is exactly what is expected and seeing numerous clinical evaluation review observations made to this effect.  I would more use the approach of State of the Art showing these type of devices use silicone in medical applications and have been used for 'x' years rather than trying to show equivalency to another device.  Then you can refer back to your pre-clinical/non-clinical testing showing the silicone material is biocompatible used in your device.​

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

Original Message:
Sent: 22-Jan-2022 13:44
From: Tim Lawton
Subject: MDCG 2020-5 Clinical Evaluation - Equivalence

Hello All,

I've been working on the MDCG 2020-5 Clinical Evaluation - Equivalence in an attempt to find an appropriate work around about with respect to MDR, Annex XIV Part A(3) : Biological Characteristics :
" the device uses the SAME materials... in contact with the same human tissues...."

This is for a new device going to market for the first time under MDR, class IIa.

The intention is to establish "equivalence" and not "similar" with a device followed by appropriate literature support, so :
- both devices are in contact with the skin (intact)
- both devices are in contact with the same human tissues
- both devices are "for a similar kind & duration" of contact..

The patient contact is silicon for our device, obviously we now the exact details, etc etc.
However, the sticking point is that we don't know what the "equivalent" device contact material is, we suspect its silicon...  it looks a feels its, unfortunately it is not mentioned anywhere in the technical details available for their device...
So, the only "common aspect" we can be certain of it that both our device and the "equivalent" device are conform to ISO10993-1, -5, -10.
I strongly believe that we can demonstrate that silicon is a well established material, in the medical field & such use cannot have an impact on "safety & clinical performance".

I have yet to approach our Notified Body about this, but I wonder how anyone else have managed this... As I can believe there is going to be a major problem for many devices trying to push through the Clinical Evaluation using "equivalent" device.... but not having proof of the "same materials".

Any experience anyone ?

Thanks
Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal
Aix-en-Provence
France
------------------------------

Original Message:
Sent: 1/22/2022 1:44:00 PM
From: Tim Lawton
Subject: MDCG 2020-5 Clinical Evaluation - Equivalence

Hello All, 

I've been working on the MDCG 2020-5 Clinical Evaluation - Equivalence in an attempt to find an appropriate work around about with respect to MDR, Annex XIV Part A(3) : Biological Characteristics : 
" the device uses the SAME materials... in contact with the same human tissues...."

This is for a new device going to market for the first time under MDR, class IIa.

The intention is to establish "equivalence" and not "similar" with a device followed by appropriate literature support, so :  
- both devices are in contact with the skin (intact)
- both devices are in contact with the same human tissues
- both devices are "for a similar kind & duration" of contact..

The patient contact is silicon for our device, obviously we now the exact details, etc etc.
However, the sticking point is that we don't know what the "equivalent" device contact material is, we suspect its silicon...  it looks a feels its, unfortunately it is not mentioned anywhere in the technical details available for their device... 
So, the only "common aspect" we can be certain of it that both our device and the "equivalent" device are conform to ISO10993-1, -5, -10. 
I strongly believe that we can demonstrate that silicon is a well established material, in the medical field & such use cannot have an impact on "safety & clinical performance". 

I have yet to approach our Notified Body about this, but I wonder how anyone else have managed this... As I can believe there is going to be a major problem for many devices trying to push through the Clinical Evaluation using "equivalent" device.... but not having proof of the "same materials". 

Any experience anyone ? 

Thanks 
Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal
Aix-en-Provence
France
------------------------------

Yes Sir,

The same issue is with us. There are some points in the IFU that is mentioned by taking reference from predicate device IFU.
But during search there is no literature found for the same , the reference taken from well reputad organizations so they must have data.
But we have only their reference. So I hope it will be accepted by notified body.

------------------------------
AP
------------------------------

Original Message:
Sent: 24-Jan-2022 07:15
From: Ted Heise
Subject: MDCG 2020-5 Clinical Evaluation - Equivalence

 

 

 

Hi Tim,

 

I essentially agree with Richard on this.  My understanding is that the NBs expect any sponsor to have access to the technical documentation of a device they wish to demonstrate as equivalent.  Without that, it seems unlikely you can succeed.

 

Best regards,

 

Ted

 

 

 

 

Original Message:
Sent: 1/22/2022 1:44:00 PM
From: Tim Lawton
Subject: MDCG 2020-5 Clinical Evaluation - Equivalence

Hello All,

I've been working on the MDCG 2020-5 Clinical Evaluation - Equivalence in an attempt to find an appropriate work around about with respect to MDR, Annex XIV Part A(3) : Biological Characteristics :
" the device uses the SAME materials... in contact with the same human tissues...."

This is for a new device going to market for the first time under MDR, class IIa.

The intention is to establish "equivalence" and not "similar" with a device followed by appropriate literature support, so :
- both devices are in contact with the skin (intact)
- both devices are in contact with the same human tissues
- both devices are "for a similar kind & duration" of contact..

The patient contact is silicon for our device, obviously we now the exact details, etc etc.
However, the sticking point is that we don't know what the "equivalent" device contact material is, we suspect its silicon...  it looks a feels its, unfortunately it is not mentioned anywhere in the technical details available for their device...
So, the only "common aspect" we can be certain of it that both our device and the "equivalent" device are conform to ISO10993-1, -5, -10.
I strongly believe that we can demonstrate that silicon is a well established material, in the medical field & such use cannot have an impact on "safety & clinical performance".

I have yet to approach our Notified Body about this, but I wonder how anyone else have managed this... As I can believe there is going to be a major problem for many devices trying to push through the Clinical Evaluation using "equivalent" device.... but not having proof of the "same materials".

Any experience anyone ?

Thanks
Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal
Aix-en-Provence
France
------------------------------

Thanks for the feedback. 

The way I see it is at the end of the day for the MDR, a company should decide NOT to use the term "equivalent device", but use "similar device" through-out their documentation (CEP, CER, Risk Analysis, etc etc). 

Especially, if the Notified Bodies applies the MDR as it is written... I cannot see how any manufacturer of the following can claim "equivalence" with devices in many fields, for example : 
- radiological devices (paint finished  & in patient contact)
- body sensors (plastic, paint, materials in patient contact)
- ... 

This is really a shame, if this becomes a sticking point for the Notified Bodies
And will further more add a distinction between the USA & Europe. 

It would be great, to know how everyone is getting on with the Notified Bodies & how they are applying (or ignoring) this point on "devices using same materials"

Thanks
Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal Consultant
Aix-en-Provence
France
------------------------------

Original Message:
Sent: 25-Jan-2022 11:56
From: Amita Pandey
Subject: MDCG 2020-5 Clinical Evaluation - Equivalence

Yes Sir,

The same issue is with us. There are some points in the IFU that is mentioned by taking reference from predicate device IFU.
But during search there is no literature found for the same , the reference taken from well reputad organizations so they must have data.
But we have only their reference. So I hope it will be accepted by notified body.

------------------------------
AP

Original Message:
Sent: 24-Jan-2022 07:15
From: Ted Heise
Subject: MDCG 2020-5 Clinical Evaluation - Equivalence

 

 

 

Hi Tim,

 

I essentially agree with Richard on this.  My understanding is that the NBs expect any sponsor to have access to the technical documentation of a device they wish to demonstrate as equivalent.  Without that, it seems unlikely you can succeed.

 

Best regards,

 

Ted

 

 

 

 

Original Message:
Sent: 1/22/2022 1:44:00 PM
From: Tim Lawton
Subject: MDCG 2020-5 Clinical Evaluation - Equivalence

Hello All,

I've been working on the MDCG 2020-5 Clinical Evaluation - Equivalence in an attempt to find an appropriate work around about with respect to MDR, Annex XIV Part A(3) : Biological Characteristics :
" the device uses the SAME materials... in contact with the same human tissues...."

This is for a new device going to market for the first time under MDR, class IIa.

The intention is to establish "equivalence" and not "similar" with a device followed by appropriate literature support, so :
- both devices are in contact with the skin (intact)
- both devices are in contact with the same human tissues
- both devices are "for a similar kind & duration" of contact..

The patient contact is silicon for our device, obviously we now the exact details, etc etc.
However, the sticking point is that we don't know what the "equivalent" device contact material is, we suspect its silicon...  it looks a feels its, unfortunately it is not mentioned anywhere in the technical details available for their device...
So, the only "common aspect" we can be certain of it that both our device and the "equivalent" device are conform to ISO10993-1, -5, -10.
I strongly believe that we can demonstrate that silicon is a well established material, in the medical field & such use cannot have an impact on "safety & clinical performance".

I have yet to approach our Notified Body about this, but I wonder how anyone else have managed this... As I can believe there is going to be a major problem for many devices trying to push through the Clinical Evaluation using "equivalent" device.... but not having proof of the "same materials".

Any experience anyone ?

Thanks
Tim

------------------------------
Tim Lawton
Regulatory Affairs Principal
Aix-en-Provence
France
------------------------------