Hey ho - Let's talk about Medical device categories - IIa
If you create a device the chance that it falls to category II is pretty high. There are two subcategories: IIa and IIb. Find your category takes time and you might need help from a professional, and of course, you have to consult regulations.
Due to the new regulation, a lot of category I product switched to category IIa.
These are usually simple devices with a BUT. For example: probiotic tampons were a category I devices, they help you maintain your health, if you are a female. But, the regulation changed and states that if a device stays in the body for more than 60 minutes it falls to the category IIa (which is unfair, but we can discuss it in another post). Who would use a tampon that they can use for only 1 hour? Will the company start the categorisation? Maybe, or maybe instead they chose not to call it a medical device anymore. This is a perfect example of a business decision. It depends on you. Maintain the medical device status to keep the nice marketing or not. Before you ask: Condoms are IIb :)
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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.