Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence

TheMightyWife

Involved In Discussions
#1
I'm writing/correcting our CER where we had a nonconformity raised for the demonstration of equivalence:
'The equivalence rationale presented for the XXXXXXXX was not clear that the materials of the construct were the same and the clinical impact of minor differences in design noted were not fully justified'

We have used as comparison widely available product sold by many other manufacturers, they are all manufactured to the same standards (dimensional etc) but other manufacturer will never disclose to me what process he is using to manufacture (for coating) and what exact type of materials.

So how can I justify any differences (if there are any) in materials and design?

Your comments are greatly appreciated!
:thanx:
 
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Marcelo

Inactive Registered Visitor
#2
Unfortunately, if you don't have this information, you can't justify the differences and conclude there's no impact on safety and performance. This is now of the things that this highlighted emphasis on equivalence has prevented - if you do not have access to information, there's no way you can use equivalence to these devices.
 

TheMightyWife

Involved In Discussions
#3
Thank you @Marcelo Antunes
In this case how other manufacturers address this issue? Request data from other manufacturers and sign NDA? Or use another route?
What are my options in this case?
I also noticed that BSI is a lot more strict than SGS in terms of assessing Tech Doc Files lol
 

Marcelo

Inactive Registered Visitor
#4
Usually when asked (not all NBs are the same, as you mentioned BSI has been a lot more strict than others), they do not use that specific device as their equivalence. If there's the only one, this may be a problem. In particular, requesting data from other manufacturers is not a good option, because generally they have not interest in helping you (as you are usually are competitors).
 

SKM.Sunil

Involved In Discussions
#5
I'm writing/correcting our CER where we had a nonconformity raised for the demonstration of equivalence:
'The equivalence rationale presented for the XXXXXXXX was not clear that the materials of the construct were the same and the clinical impact of minor differences in design noted were not fully justified'

We have used as comparison widely available product sold by many other manufacturers, they are all manufactured to the same standards (dimensional etc) but other manufacturer will never disclose to me what process he is using to manufacture (for coating) and what exact type of materials.

So how can I justify any differences (if there are any) in materials and design?

Your comments are greatly appreciated!
:thanx:


Please correct me if I understood your point,
2nd Para: You have compared with many devices of the same kind and configuration, and you want to know the manufacturing process.?

My Answer: the material of construction should be the same for the demonstration of equivalence. In process manufacturing techniques doesn't have anything to do with equivalence as long as the finished products are the same and have the same intended application in similar area. you have mentioned that you want to know coating process/technology--In any circumstances, no manufacturer will give access to that data, what you can only have access is what is the primary material of the coating. (it may be present on IFU or Product description)
In 1st para: the evaluator comment is focused on the material of construction, not the process.

As per Meddev2.7.1/4, one device is sufficient to demonstrate the equivalence (max 2 devices is a better option). You don't have to go for several devices, unless you will end up in messing the conclusion on safety and performance. Try to minimise the content and maximize the conclusion.

They asked to justify the minor difference you have highlighted in the Evaluation Report. In such a case, you have to demonstrate the difference you have, how it is clinically providing a better result to the end user ( this is a must). You can add PMCF investigation plan to highlight, how you are planning to provide more clinical data on this.

In addition, I can suggest if you don't have access to other manufacturers data, you can always do an in-house test/laboratory evaluation to get some data. ( this process must be valid and accurate result must be demonstrated. any kind of modification or alteration of data in favour of your device may lead to some consequences with other manufacturers)

Hope, This may help you in any way. Thanks
 

Marcelo

Inactive Registered Visitor
#6
Please correct me if I understood your point,
2nd Para: You have compared with many devices of the same kind and configuration, and you want to know the manufacturing process.?

My Answer: the material of construction should be the same for the demonstration of equivalence. In process manufacturing techniques doesn't have anything to do with equivalence as long as the finished products are the same and have the same intended application in similar area. you have mentioned that you want to know coating process/technology--In any circumstances, no manufacturer will give access to that data, what you can only have access is what is the primary material of the coating. (it may be present on IFU or Product description)
In 1st para: the evaluator comment is focused on the material of construction, not the process.
The manufacturing process surely can contribute to the equivalence evaluation. For example, if finished device have both the same materials, but different sterilization methods, you cannot guarantee that the safety and performance are the same. This can be the same for some specific manufacturing processes, such as coating.

But you are tight they are asking for materials this time, not manufacturing processes. In this case, the OP could perform a material characterization (for example, per iSO 10993-18), and if the same as the op device, may conclude that the biological risks are the same 9but it still needs and evaluation and justification).
 

SKM.Sunil

Involved In Discussions
#7
The manufacturing process surely can contribute to the equivalence evaluation. For example, if finished device have both the same materials, but different sterilization methods, you cannot guarantee that the safety and performance are the same. This can be the same for some specific manufacturing processes, such as coating.

But you are tight they are asking for materials this time, not manufacturing processes. In this case, the OP could perform a material characterization (for example, per iSO 10993-18), and if the same as the op device, may conclude that the biological risks are the same 9but it still needs and evaluation and justification).

Yes, I agree with you. we have to demonstrate the process (e.g. drying, coating, packaging, sterilization), but we may not be given access to technologies that other manufacturer used for this process (e.g. radiation level and exposure time etc..). That's why we need to demonstrate with clinical evidence that the difference in the process still yields the same or better result.

I think we should go with an equivalent device which have a highest degree of similarity to our device unless we would end up writing so many justifications.
 
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