Can a software that receive data from a MD be classified as Class I?or is not a MD?

Berni

Starting to get Involved
#1
A company that has telemedicine solutions wants to use our API products to integrate our devices into their software, until MDR they didn't mark the software with NB, because is only to monitor, visualize, and store data without modification. Now it is not clear if this should be a class IIa device by rule 11 or if it can remain class I due to the low risk for the patient.

In MDCG 2019-11 Decision step 3: if the software does perform an action on data, or performs an action beyond storage, archival, communication, simple search, lossless compression. In this case, the answer is no. So it would be not covered by MDR.

But on the other hand, according to rule 11, the information that the software store can be used to make medical decisions. I find this a bit contradictory. I need to provide this company with advice on its regulatory strategy, and if it is possible to avoid being classified as IIa.
 
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ECHO

Involved In Discussions
#2
What do you mean by monitor and visualize data?

Without knowing more about this software, it is hard to tell. That said, unless your software is like Dropbox, I would revisit your answer to decision step 3.
 

Junn1992

Quite Involved in Discussions
#4
I guess it depends on intended use. If the data integration is for benefitting diagnosis or aid in physician to make a decision, then for sure it is a MD. I doubt data integration is just for storage.
 

Berni

Starting to get Involved
#5
What do you mean by monitor and visualize data?

Without knowing more about this software, it is hard to tell. That said, unless your software is like Dropbox, I would revisit your answer to decision step 3.
Our device transfers the data to a computer using our API, their application is used to visualize the data and allows them to save it in the patient record.

Are you or your customer making this claim about your software?
The company already uses their software out of the UE, but they are asking us if they need to mark it as Class IIa MD

I guess it depends on intended use. If the data integration is for benefitting diagnosis or aid in physician to make a decision, then for sure it is a MD. I doubt data integration is just for storage.
This is my concern, the data can be interpreted by the physician to support their decission.
___

As the EU is not their main market, marking as class IIa won't be worth it for them. I would need to provide them with some assistance, and I'm not sure if only for EU users, they can claim that the product can't be used for diagnosis and is only the physician's responsibility to use it.
 

Junn1992

Quite Involved in Discussions
#6
This is my concern, the data can be interpreted by the physician to support their decission.
then for sure it is MD

they can claim that the product can't be used for diagnosis and is only the physician's responsibility to use it.
this also qualifies as MD since it displays data for diagnosis.

I do not see a way around this for the EU. Whereas for example in Vietnam, where software is currently not regulated, it would be relatively easy to do it.
 
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