Let's continue with everyone's favorite mini series!
Medical device categories: IIb
Does it have emission like x-ray? Does it contact the patient on longer term? Is it a contraceptive or does it prevent sexually transmitted disease? Is it implantable?
Then my friend it's a IIb product, good news: it's not that bad, bad news: it is not simple, and the cerification cost is significantly higher.
You have several parameters to be proven by third party labs, like biocompatibility, EMC.
If you are new to the business you definitely need to consult with someone who's experienced in this topic!
No comments yet
Be the first to comment
Download Qoorio to talk & learn from other Humans
MORE INSIGHTS YOU MIGHT LIKELearn more by discovering other insights
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.