CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4

Harini17

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#1
Dear Experts,

I have a major question with respect to equivalent devices. I have recently came across a report where they are preparing report for two subject devices and claiming equivalence using the same i.e, without considering other devices as equivalent. My question is can we consider subject devices as equivalent devices having different user group - one is pediatric, adult (>9kg) and the other one is only adult (>30 kg). Technological features are same but there is a bit difference in size. Can I consider subject devices as equivalent devices?

It would be great if you could list down the criteria to be considered for equivalent devices?

Thanks
 
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QAengineer13

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#2
Dear Experts,

I have a major question with respect to equivalent devices. I have recently came across a report where they are preparing report for two subject devices and claiming equivalence using the same i.e, without considering other devices as equivalent. My question is can we consider subject devices as equivalent devices having different user group - one is pediatric, adult (>9kg) and the other one is only adult (>30 kg). Technological features are same but there is a bit difference in size. Can I consider subject devices as equivalent devices?

It would be great if you could list down the criteria to be considered for equivalent devices?

Thanks

Hi Harini,

"My question is can we consider subject devices as equivalent devices having different user group - one is pediatric, adult (>9kg) and the other one is only adult (>30 kg). "

The simple answer is NO because the pediatric population represents a particularly vulnerable group, specific measures are needed to protect the safety of pediatric study subjects. Adult devices may be inappropriate for use in pediatric subjects for a variety of reasons, or may require specific
design changes and/or specific labeling to accommodate their use in pediatric subjects.

Also the Intended use and the indication for use and other factors play a vital role its not just the technology ...this is my 2C's.

But devil is in the detail, my quick answer to you would be No, but need more specifics from you to understand your case.
 

paulag

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#3
Hi Harini,

Meddev itself gives you all the criteria regarding equivalence - and the answer to your question is no...

"used in a similar population (this may relate to age, gender, anatomy, physiology, possibly other aspects),"​

DocsRoom - European Commission


Dear Experts,

I have a major question with respect to equivalent devices. I have recently came across a report where they are preparing report for two subject devices and claiming equivalence using the same i.e, without considering other devices as equivalent. My question is can we consider subject devices as equivalent devices having different user group - one is pediatric, adult (>9kg) and the other one is only adult (>30 kg). Technological features are same but there is a bit difference in size. Can I consider subject devices as equivalent devices?

It would be great if you could list down the criteria to be considered for equivalent devices?

Thanks
 
#4
Hello,

From MDR perspective, there are some specific requirements in the text that requires a manufaturer to have an agreement in place with a manufaturer of reference device in order to have full access to their technical documentation. Other than that, the manufaturer of the device to which an equivalence will be established also needs to be MDR compliant from CER standpoint.

This is still far away (not so though) and may not apply to your case if the manufacturer is the same for both the devices anyways. Even though not considering MDR, I guess the equivalence cannot be established between the two group of devices that you are referring to, the major reason being the difference in the intended target population.

Refer to Art. 61 (Clinical Evaluation) for MDR equivalence criteria. More details can be found in MedDev Rev 4.
 
#6
Hello,

I need some clarification in equivalent device. Our product is CE marked/certified since 2010. Now we are in re-certification process. In this case still we need to prove with any equivalent device with our device? Also the re-certification process initiated with the same NB, who certified us in 2015 (as per Rev3), in this case, do we need to prove the equivalence with equivalent device to the same NB again.
 

FoGia

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#7
The short answer is: yes. The CER is a standalone document that could be reviewed by a party without prior knowledge of the device.

You will also need to update the demonstration of equivalence following the criteria listed in the rev 4.
 
#8
Dear FoGia,

Thanks for your reply. As per the Meddev 2.7.1/4, in page number 16 of 65, it was given as "Information needed for evaluation of equivalence, if equivalence may
possibly be claimed
" Applicable for Before CE marking. Still the NB insisting us to prove the equivalence of equivalent device. Don't know why..?
 

FoGia

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#9
There is indeed confusion regarding this table. Nowhere is it stated in the MDD that you can't rely on equivalency after your device has been CE-marked. The table assumes that after CE-marking you have gathered sufficient data on your own. Still, as long as you claim equivalency to leverage the data from another device you have to demonstrate it in every CER (according to the rule that a CER should be a standalone document)?
 
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