Technical File Assessment from a NB - Clinical Equivalence

[CHDKPT]

Hi,

I have received an assessment from a NB for a technical file submission that we are obtaining CE mark for and it mentions the following:
"Demonstrate that your device is identical to the predicate which on a general level is accepted- However for demonstration of equivalent clinical performance Penetration depth, resolution etc. needs to be demonstrated equivalent. As per reply (email dated) the devices are equivalent and this is supported by statement form the supplier, which is accepted – However since the clinical use is with a scanner it makes no sense in comparing and verifying equivalence of the transducers without including the scanner.

The device being cleared is a class IIa probe which is a device in its own rights, how can I argument that the NB has already cleared the scanner and all the safety and performance control measures in it and that this assessment is for the probe only.

Thank you for any help

 

[yodon]

Could be a tough one.

Does the same scanner take your probe and the predicate probe? If so, showing that it takes the same inputs / provides the same outputs _might_ be a reasonable argument.

The more closely you can provide apples-to-apples data - even back to the platform - would seem the best approach.

 

[Ronen E]

Hi,

I have received an assessment from a NB for a technical file submission that we are obtaining CE mark for and it mentions the following:
"Demonstrate that your device is identical to the predicate which on a general level is accepted- However for demonstration of equivalent clinical performance Penetration depth, resolution etc. needs to be demonstrated equivalent. As per reply (email dated) the devices are equivalent and this is supported by statement form the supplier, which is accepted – However since the clinical use is with a scanner it makes no sense in comparing and verifying equivalence of the transducers without including the scanner.

The device being cleared is a class IIa probe which is a device in its own rights, how can I argument that the NB has already cleared the scanner and all the safety and performance control measures in it and that this assessment is for the probe only.

Thank you for any help

Hello CHDKPT and welcome to the Cove

As a general rule, if you have 2 different transducers that work with 2 different scanners to produce the same clinical performance, it doesn't necessarily support that the 2 (different) transducers are clinically equivalent. They may well be not, and since - as you state - the transducer/probe is being cleared as a medical device in its own right, you may actually have a real problem.

Apart from that general comment, your query has left me somewhat confused as to who-said/approved-what (your org, the NB, your scanner supplier/manufacturer, the other probe supplier/manufacturer etc.). It's also a little difficult to understand what that system is and what it does and what's the relationship between the probe or system you're trying to qualify and any other reference points. If you could start from the beginning and describe the situation by a list of discrete facts, that might help.

Cheers,
Ronen.

 

[CHDKPT]

Hi Ronen,

Thank you for your reply. Our scanner has been cleared along with more then 20 transducer types. This one is nevertheless for a diferent indication for use and therefore we could not self-certify (was not on our CE scope). The text within "" is the reply from the NB to a non-conformity in their technical assessment, to which they accept we demonstrated that our device is identical to the predicate which on a general level.
The transducer that is being cleared is exactly the same as a Toshiba transducer (with the exception of the connector cable), for which we have a confirmation statement from the vendor. This Toshiba transducer works on their scanner only and ours on our scanner. They have written a non-conformity on lack of conformance with MEDDEV 2.7/2 rev. 4, a document that most NBs are not addopting yet and that is not legally binding, based not in its predicate but on its integration in a system that is approved and has been in the market for some years. The Toshiba transducer has also been on the market for quite a long time.
Any further feedback helps

 

[CHDKPT]

Hi Yodon,


Thank you for your reply. Our scanner has been cleared along with more then 20 transducer types. This one is nevertheless for a diferent indication for use and therefore we could not self-certify (was not on our CE scope). The text within "" is the reply from the NB to a non-conformity in their technical assessment, to which they accept we demonstrated that our device is identical to the predicate which on a general level.
The transducer that is being cleared is exactly the same as a Toshiba transducer (with the exception of the connector cable), for which we have a confirmation statement from the vendor. This Toshiba transducer works on their scanner only and ours on our scanner. They have written a non-conformity on lack of conformance with MEDDEV 2.7/2 rev. 4, a document that most NBs are not addopting yet and that is not legally binding, based not in its predicate but on its integration in a system that is approved and has been in the market for some years. The Toshiba transducer has also been on the market for quite a long time.
Any further feedback helps

 

[Ronen E]

Hi Ronen,

Thank you for your reply. Our scanner has been cleared along with more then 20 transducer types. This one is nevertheless for a diferent indication for use and therefore we could not self-certify (was not on our CE scope). The text within "" is the reply from the NB to a non-conformity in their technical assessment, to which they accept we demonstrated that our device is identical to the predicate which on a general level.
The transducer that is being cleared is exactly the same as a Toshiba transducer (with the exception of the connector cable), for which we have a confirmation statement from the vendor. This Toshiba transducer works on their scanner only and ours on our scanner. They have written a non-conformity on lack of conformance with MEDDEV 2.7/2 rev. 4, a document that most NBs are not addopting yet and that is not legally binding, based not in its predicate but on its integration in a system that is approved and has been in the market for some years. The Toshiba transducer has also been on the market for quite a long time.
Any further feedback helps

Hi,

Thanks for your attempt to clarify. I hope I got the gist of it.

First, regarding MEDDEV 2.7/1 rev. 4 - it's not legally binding but unfortunately NBs seem to apply it as such. I'm not sure why you state that most NBs are not adopting it yet - my impression has been to the contrary.

With regards to your situation - I understand that your probe and the one presented as "equivalent" in your CER (the Toshiba probe) are actually the same product - as certified by its manufacturer, with the exception of the cable & connector. Is that right? If so, you first have the onus of establishing that the cable and connector don't make any relevant difference. Once you have that sorted, you still need to show that the probes are clinically equivalent. This might be tricky despite their technological similarity, because their clinical performance - so I understand - can only be demonstrated, and is actually only reported, with a specific scanner. Are the scanners equivalent too? I suspect not.

The fact that the Toshiba probe has been on the market for a long time doesn't help you a lot, because it has (apparently) been used with the Toshiba scanner which is different from yours. Correct?

the fact that your scanner has been on the market for a long time doesn't help you much either in the current context, because - as you've highlighted yourself - it was used with other probes which are (apparently) substantially different. Otherwise the "new" probe wouldn't have fallen outside your existing scope.

I must say that your NB's argument doesn't currently seem outrageous to me. However, I may have simply misunderstood you.

 

[CHDKPT]

Hi Ronen,

Have you read the lastest EMERGO RADAR post on this MEDDEV and BSI´s white paper in Generating-clinical-evaluation (page 4)?
Also the MEDDEV document itself states that. Disclaimer in the cover page.

I find the assessment quite unreasonable, considering the difficulty that manufacturers have establishing equivalence with a device where they do not have access to the STED files. Especially when you have a statement from the vendor on the clinical equivalence between these devices extending to connector equivalence, and that the vendor also confirmed that no differences are expected from the side of the probes, which is what is being assessed. Risk analysis/management is in place with collaboration of the vendor, PMS reports in place, clinical equivalence discussion on the probe has even been accepted...
Of course, we cannot establish equivalence with the scanner. We don’t have their technical files and it is extremely difficult to obtain a competitor system for testing.
But I believe that there are innumerous manufacturers that believe that the requirements for the MEDDEV 2.7/1 is excessive or even unacceptable and that NBs have no business writing NCs based on non-legally binding documents or non-harmonized standards. But its part of life in this business.