EU MDR & IVDR Device Class Finder
Get a suggested device class based on typical EU MDR (medical devices) or IVDR (in vitro diagnostics) rules. Use the result in our EU AR cost calculator and when comparing EU Authorized Representative providers.
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Use your class in the cost calculator
EU Authorized Representative pricing often depends on device class. Take your result to our EU AR cost calculator (select the matching class), then request quotes from vetted providers.
Official classification
Definitive classification is per MDR Annex VIII and IVDR Annex VIII. This tool gives a typical suggestion only; document your classification and justification in your technical documentation. In case of doubt, consult a notified body or regulatory consultant.
This tool is for planning only and does not constitute legal or regulatory advice. Final classification is the manufacturer’s responsibility under MDR/IVDR. See our Privacy Policy.