Clinical Evaluation of equivalent device

[SimSim]

Hello Everyone, I wanted to know can we claim equivalence with our own manufactured device which is similar TO OUR SUBJECT DEVICE UNDER EVALUATION. The equivalent device we will be using is substantial equivalent as a predicate device in 510k submission and can we claim the same equivalent device/predicate device in the MDR EU submission??

 

[Ed Panek]

Why is this new device (Which is equivalent to the predicate) requiring a new 510(k)? Is it part of the same family? Does the predicate still exist on the market?

Have you reviewed the FDA 2017 guidance on "When to Submit a New 510(k)?"

 

[SimSim]

The device under evaluation and equivalent device is already 510k approved. I would like to know if I can submit it for EU MDR Certification.
The subject device and equivalent device (Predicate device under 510k)..... can I use it for demonstration of equivalency for MDR?

Both the devices are MDD certified as well. They are still in EU market with MDD certificate

 

[Watchcat]

If you are asking if there is some reason it is excluded from being an equivalent because it is your device, as far as I know, there is not.

If you are asking whether your NB will accept it as equivalent per the MDR because FDA accepted it as substantially equivalent per FDA regulations, without you needed to provide any further justification, only your NB can say.

I would definitely not say "because FDA said so. " Instead, I would provide the same justification that was provided to FDA, and leave FDA out of it. I don't think all NBs enjoy being told that FDA is the authority on all things medical devices, not them.

So I think that means the real question is whether the justification that was provided to FDA will suffice for your NB. Again, only your NB can say, but I would suggest you think about the matter in those terms, consult the MDR and any EU relevant guidance that has been issued regarding equivalence, and then see what you come up with.

 

[dgrainger]

Check out MDCG 2020-5 - Clinical Evaluation - Equivalence A guide for manufacturers and notified bodies

https://ec.europa.eu/health/sites/d...idance_clinical_evaluation_equivalence_en.pdf

 

[SimSim]

If you are asking if there is some reason it is excluded from being an equivalent because it is your device, as far as I know, there is not.

If you are asking whether your NB will accept it as equivalent per the MDR because FDA accepted it as substantially equivalent per FDA regulations, without you needed to provide any further justification, only your NB can say.

I would definitely not say "because FDA said so. " Instead, I would provide the same justification that was provided to FDA, and leave FDA out of it. I don't think all NBs enjoy being told that FDA is the authority on all things medical devices, not them.

So I think that means the real question is whether the justification that was provided to FDA will suffice for your NB. Again, only your NB can say, but I would suggest you think about the matter in those terms, consult the MDR and any EU relevant guidance that has been issued regarding equivalence, and then see what you come up with.

Thank you very much for the explanation. You answered all the questions I had doubts about.

Well, we decide to use the predicate device as our equivalnet device for MDR submission and will see what NB says.

 

[Sierra]

I'd like to hear how this goes if you can remember to come back and update. In a similar situation with IVDR. (We have been asked (kindly) why we have US-related regulations, etc. listed in our IFU, etc. so I totally agree with not telling them the FDA said it was OK!)

 

[Muhammad Farooq]

Thank you very much for the explanation. You answered all the questions I had doubts about.

Well, we decide to use the predicate device as our equivalnet device for MDR submission and will see what NB says.

Please update us also about the NB response. Thank you.