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MDClassify provides an indicative, preliminary classification of medical devices based on the questionnaire answers you provide. It is an informational tool only. It does not constitute legal, regulatory, or professional advice, and it is not a substitute for the formal classification rationale required in a technical file, nor for the involvement of a Notified Body where applicable.
Results are provided "as is", without any guarantee of accuracy or completeness. You are solely responsible for verifying any classification with a qualified regulatory affairs professional before relying on it for regulatory submissions or market access decisions. To the maximum extent permitted by law, MDClassify is not liable for any decision made based on the output of this tool.
The single-market EU MDR classification is provided free of charge. Additional cross-market reports, when available, will be offered on a paid, one-time basis under terms shown at the time of purchase. [Editable placeholder: add refund policy and payment terms once the paid tier is live.]
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