Software as a Medical Device Classification Rule 11 (EU MDR 2017/745)

► podcast.easyme...
This new Rule 11 for the classification of software from the EU MDR 2017/745 is really creating a lot of questions to software developers.
But this is not really something that existed before so this is the reason why it creates a lot of debates. With the MDD 93/42/EC, the idea of software as a Medical Device was not so popular. But now, all is software so this was a good reason to update that.
Cyrille Michaud from MD101 Consulting will help us understand this rule and the differences with the directive. He is a software developer so it's his specialty to help us solve those issues.
About Cyrille Michaud
Based in France, Cyrille Michaud is managing partner as MD101 Consulting. He is an information technology engineer with experience in both software and Quality Affairs/Regulatory Affairs. Prior to his current position, he was project director in a medical imaging start-up. His main achievements were the ISO 13485 certification and the CE Mark and FDA clearances. The value he brings: solving technical and regulatory issues, building business plans and regulatory strategies for manufacturers of software medical devices.
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Links from the Video
■ MD101 Consulting website: www.md101consulting.com
■ MD101 Consulting Linkedin Page:
/ md101-consulting
■ Cyrille Michaud Linkedin:
/ cyrillemichaud
■ Blog Cyrille Michaud: blog.cm-dm.com/
■ Rendez-Vous Expert Medtech: expertsmedtech...
■ Episode 15 - MDR and IVDR with Erik Vollebregt: podcast.easyme...
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Social Media to follow
Linkedin: / melazzouzi
Twitter: / elazzouzim
Pinterest: / easymedicaldevice
Instagram: / easymedicaldevice
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#medtech #medicaldevice #compliance

[@EasyMedicalDevice]

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.

[@getreshmi]

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.

[@EasyMedicalDevice]

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.

[@paulcampbell3950]

A very helpful Podcast on MDR, in particular, SaMD. Thanks

[@EasyMedicalDevice]

Thanks Paul Campbell, really appreciated. I will try to have more people to talk about this topic

[@serenityzone7399]

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.

[@dhruvagrawal6832]

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 ?