What class is my Medical AI? MDR Rule 11 explained
MDR Rule 11 governs the classification of medical device software, and it is notoriously consequential: most software that provides information used for clinical decisions lands in Class IIa or higher. Your class determines your conformity route, evidence and obligations.
Run this assessment free →How Rule 11 works
Rule 11 classifies software by the significance of the information it provides to a clinical decision and the state of the patient. Software intended to provide information used to take decisions with diagnostic or therapeutic purposes is typically Class IIa, rising to IIb or III where decisions could cause serious deterioration or death. Software for monitoring physiological processes has its own provisions.
MDR class vs software safety class
A frequent confusion: the MDR risk class (I–III) is not the same as the IEC 62304 software safety class (A/B/C). The former drives your conformity route; the latter drives the rigour of your software lifecycle. You need both, determined separately.
Aligning FDA and UK
The same software typically maps to an FDA pathway (510(k) or De Novo, depending on predicate availability) and a UK class that mirrors the EU logic post-Brexit. A defensible classification documents all three in parallel, with the clinical-significance argument front and centre.