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.
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.