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Frequently asked questions
How reliable is the result?
The tool applies the classification rules in Annex VIII of the MDR / IVDR and the relevant MDCG guidance step by step. The result is a preliminary assessment based on your answers – it is not a notified-body decision. The intended purpose stated by the manufacturer decides the class, so describe it as precisely as possible.
What if my product has several parts?
Tick “multi-component product” in step 1 and name each part (e.g. console, probe, software). Each part is classified separately; accessories are classified in their own right.
What if I am unsure or cannot answer a question?
Use “Send to EVERBIZ” below the tool: upload your IFU, labels, photos or technical data and describe your question. Our regulatory team will review it and classify with you – this does not count as a free use.
Why do I log in with my e-mail, and how often can I use it?
You log in with a code sent to your e-mail – no password needed. Each e-mail address gets 3 free results; viewing the result of the same product again does not count. Contact us if you need more.