@@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?
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
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
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. ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-y4mW9KdAuU8.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.
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.
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.
