What's your device class?
5 questions to classify your device under EU MDR 2017/745 and UKCA. Instant result — no signup.
Not a legal determination
This tool gives an indicative classification based on the information you provide. It does not constitute regulatory advice. Device classification can be complex — devices that interact with the body, emit ionising radiation, or have a mode of action that is not well-established may require formal consultation with a Notified Body or the MHRA to confirm their class. Always verify with your RA team or regulatory consultant before making compliance decisions.