@@EasyMedicalDevice I downloaded your free classification form and found something that doesn't seem to align with the MDR. Rule 7, with medicinal product. Your sheet says IIa but the MDR seems to suggest IIb. Did I misunderstand something in this?
Is wi-fi device which control blood bank refrigerators consider medical device ? It is an option add to medical device for monitoring and controlling temperature and failure alarm also ? Thanks
This was really helpful. Thank you. Do you have any videos or blogs that offer guidance whether to submit separate items as individual 'devices', or whether to submit them as a 'system'.
Hi Jon, if to achieve its intended purpose a product should be combines to another then you should present the system. If each of them can work individualy it can be presented alone. An accessory to a Medical Device should work with the device so this one achieve its intended purpose so you should have then together for example
Hi!! Great video! But I'm not see clearly the difference betwen "partial Certificated" and "certificated" from a Notify body. I mean, the certificated betwen one medical device Class 1s or 1m and Class 2a, 2b,3. I thought that the certificated from the notify body would be the same. Thanks a lot!
Hi, thanks for your comment. Regarding your question I published a podcast Episode with Elem Ayne where we review the elements you mention. th-cam.com/video/y4mW9KdAuU8/w-d-xo.html
It is considered as a Medical Device. Normally an anti-acid has some ingredients that will be alcaline. This will reduce the acidity of the stomach. There is no active substances. With the new Medical Device Regulation, rule 21 these products may be upclassified.
No this was a mistake in the wording used. It is IIb per rule 9. The device that is recording X-Ray information coming from the machine is class IIa rule 17.
Yes. This has no pharmacological, metabolical or immunological action. It is just a chemical reaction to relief the user from burning stomach. The substance primary action is to increase the stomach pH.
![How to create your Medical Device Technical File [EU MDR & IVDR]](http://i.ytimg.com/vi/2cHbr5VGhSI/mqdefault.jpg)
I very much appreciate that you explained this in an easy to understand way, as well as the visual aspect of the handout you had (from your store).
Thanks. Happy that it is helping.
@@EasyMedicalDevice I downloaded your free classification form and found something that doesn't seem to align with the MDR. Rule 7, with medicinal product. Your sheet says IIa but the MDR seems to suggest IIb. Did I misunderstand something in this?
Excellent, easy to follow and understand, as always. Great work
Thanks Christian
Very appreciate of your valuable lecture, It must help me out, many thanks again
Glad to hear that
Thank you very much for this detailed information
It was my pleasure. Happy that it helps
Is wi-fi device which control blood bank refrigerators consider medical device ?
It is an option add to medical device for monitoring and controlling temperature and failure alarm also ?
Thanks
This was really helpful. Thank you. Do you have any videos or blogs that offer guidance whether to submit separate items as individual 'devices', or whether to submit them as a 'system'.
Hi Jon, if to achieve its intended purpose a product should be combines to another then you should present the system. If each of them can work individualy it can be presented alone. An accessory to a Medical Device should work with the device so this one achieve its intended purpose so you should have then together for example
Hello Mr. Azzouzi, are corn plasters with %40 salicylic acid rule 21 and class III ?
How about hospital bed. Is it class I? And need self assesment?
Can we use MDCG doc for classification?
Yes you can, but this is a guidance. If there is a conflict of information then EU MDR is the reference to take
Hi!! Great video!
But I'm not see clearly the difference betwen "partial Certificated" and "certificated" from a Notify body. I mean, the certificated betwen one medical device Class 1s or 1m and Class 2a, 2b,3. I thought that the certificated from the notify body would be the same. Thanks a lot!
Hi, thanks for your comment. Regarding your question I published a podcast Episode with Elem Ayne where we review the elements you mention. th-cam.com/video/y4mW9KdAuU8/w-d-xo.html
@Easy Medical Device, Hi, How can I Classify Endoscopy and ENT Surgical Instrument?
Can an anti-acid also be considered as a drug/medicine? Or why is it considered as a medical device?
It is considered as a Medical Device. Normally an anti-acid has some ingredients that will be alcaline. This will reduce the acidity of the stomach. There is no active substances. With the new Medical Device Regulation, rule 21 these products may be upclassified.
thank you for the nice lecture.
You’re welcome. Don’t forget to download the presentation and share it with your colleagues
X-Ray is rule 17 class IIa?
No this was a mistake in the wording used. It is IIb per rule 9. The device that is recording X-Ray information coming from the machine is class IIa rule 17.
Anti acid should be a medicine, how are we considering this as medical device?
Yes. This has no pharmacological, metabolical or immunological action. It is just a chemical reaction to relief the user from burning stomach. The substance primary action is to increase the stomach pH.
Thanks
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