MDR classification
Answer a few questions about how your device works and what it is for, and see its class under the EU MDR, the rule that decides it, and examples from the MDCG guidance.
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Tell me about your device and its intended purpose, and we will go through the classification and what it means for your route to the CE mark.
class
The tool gives an indicative class based on the intended purpose you describe. The final classification depends on the full intended purpose and is confirmed with your notified body.
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Tick only what the intended purpose says. If nothing fits, leave it empty.
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Class
Answer the questions and tick what fits your device. The class and the rule behind it will appear here.
Your device class
When several rules apply, the strictest one decides the class (MDR Annex VIII, 3.5).
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.