Medical device categories
A wide range of products can be medical device. From cotton pads to seizure preventing implanted microchips. You can easily understand that they will not be handled the same way. That is why we have categories!
Let's jump into category I: they are the simplest devices, they are basically helpful for the physician, and the risk of their use is minimal. Some of them may come sterile, e.g.: spatulas, cotton swabs. Some software is also belong to this category. Good news: these are the easiest products in the aspect of regulatory. You only need to provide the local authority with the medical device file, and you are good to go in the EU!
Categorization is not a piece of cake! Always consult with a professional!
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Be the first to commentYou successfully checked MDR but got frightened? Categories? Quality assurance? Clinicals? What the...
Yes, it is quite complicated, but you shouldn't be worried!
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IVD - the special
Is your medical device meant to diagnose by checking human-derived samples? (blood, saliva, urine...etc.)Congrats! You have an IVD! You need to follow the IVDR instead the MDR. You will have different categories, than Medical devices, but all other basic principle are the same!
This topic is not easy! Always consult with a professional.
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