Software CE Marking

Software Classification

The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD to which the SOFTWARE SYSTEM can contribute.

Software CE Marking depends on the type and risk class of the software in question. The software safety classes shall initially be assigned based on severity as follows:

  1. Class A: No injury or damage to health is possible
  2. Class B: Non-SERIOUS INJURY is possible
  3. Class C: Death or SERIOUS INJURY is possible

The software needs to classify as per Medical Device Regulation. The class of medical software can be easily found out if it is used in connection with other Medical Equipment. If it is used as a standalone equipment based on the Risk analysis and Indended application the class can be found out

How Medical Device are Classified as per MDR? >>

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