Thanks to Cyrille Michaud for his masterclass on the new classification rule 11 for Software devices. Don't hesitate to tell us if you liked it or if you have more questions.
Hello, Thanks for the amazing webinar. I do have one questions though. Currently upper limb myoelectric prosthesis are classified under Class 1. They use EMG sensors to pick us muscle signal and move the prosthesis. But these signal data is considered under non-measuring function - because the sensor data is not compared with a baseline or given to the patient or doctor What do you think will happen under MDR ? Will the software used within the prosthetic hand classify it as Class II A. Or will it remain Class 1 ?
This is a very useful and informative podcast. Can you cover Validation of SaMD and more specifically instances where e record requirements are in scope and not in scope. Thank you.
Is a medication dispenser considered as a medical device as per MDR or MDD? I mean an automated medication dispenser which has an inbuilt software that controls scheduling, organizations, and timely delivery of multidose drug pouches.
Hi Getreshmi, from the definition of your product, I see that it includes a software that will define when the person should take his medicines which is then falling on the therapeutic area. If your software is making a wrong decision because maybe it's not well validated then it can maybe damage the life of your patient. It depends also on the medicine that it will take care of. It is really borderline but I think this is a Medical Device. For the classification, we should look at rule 11 but as the medicine can be aspirin or pills to treat HIV / cancer then it's difficult to say if it's high or low risk.
![Is my Software a Class I Medical device? [EU MDR 2017/745]](http://i.ytimg.com/vi/EFyDm7xQ7DQ/mqdefault.jpg)
Thanks to Cyrille Michaud for his masterclass on the new classification rule 11 for Software devices. Don't hesitate to tell us if you liked it or if you have more questions.
A very helpful Podcast on MDR, in particular, SaMD. Thanks
Thanks Paul Campbell, really appreciated. I will try to have more people to talk about this topic
Hello, Thanks for the amazing webinar. I do have one questions though. Currently upper limb myoelectric prosthesis are classified under Class 1. They use EMG sensors to pick us muscle signal and move the prosthesis. But these signal data is considered under non-measuring function - because the sensor data is not compared with a baseline or given to the patient or doctor
What do you think will happen under MDR ? Will the software used within the prosthetic hand classify it as Class II A. Or will it remain Class 1 ?
This is a very useful and informative podcast. Can you cover Validation of SaMD and more specifically instances where e record requirements are in scope and not in scope. Thank you.
Is a medication dispenser considered as a medical device as per MDR or MDD? I mean an automated medication dispenser which has an inbuilt software that controls scheduling, organizations, and timely delivery of multidose drug pouches.
Hi Getreshmi, from the definition of your product, I see that it includes a software that will define when the person should take his medicines which is then falling on the therapeutic area. If your software is making a wrong decision because maybe it's not well validated then it can maybe damage the life of your patient. It depends also on the medicine that it will take care of. It is really borderline but I think this is a Medical Device. For the classification, we should look at rule 11 but as the medicine can be aspirin or pills to treat HIV / cancer then it's difficult to say if it's high or low risk.