SaMD

Software as a medical device: MDR classes I to III and IEC 62304 safety classes A to C, explained

Once software has a medical purpose, two classifications decide the work to market it in the EU: the MDR risk class (I, IIa, IIb, III) from Rule 11 sets the conformity route; the IEC 62304 safety class (A, B, C) sets engineering rigour. How each is determined, how they interact, the FDA differences, and a worked example.