Essentials of European Medical Device Regulatory Affairs - October 2019
Standalone Software - current
• Rules 9, 10,11 and 12 on active devices need to be reviewed • Current no specific rule for software in MDD
MDR- Software rule 11
If such decisions have an impact that may directly or indirectly cause: – the death or an irreversible deterioration of the state of health ‐ a serious deterioration of the state of health or a surgical intervention
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes
Class III
Class IIa
Except
Class IIb
Software intended to monitor physiological processes.
‐ If it is intended for monitoring of vital physiological parameters, where the nature of variations is such that is could result in immediate danger to the patient.
Class IIa
Except
Class IIb
All other software
Class I
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