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EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device

G

Giovanni

#1
Based on the new MDR regulation, I´m trying to understand how to perform a re-classification of a Software as Medical Device:

Software to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as Class IIA, except if such decisions have an impact that may cause:
  • Death or an irreversible deterioration of a person´s state of health, in which case it is in Class III; or
  • a serious deterioration of a person´s state of the health or a surgical intervention, in which case it is classified as Class IIB
Software intended to monitor physiological processes is classified as Class IIA, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as Class IIB.

All other software are classified as Class I.


What does that means?

I´m trying to brainstorm:
If you are developing a SW which provide information ( any information or the most relevant information?) the Medical Operator can use for diagnosis (like: Sofwtare with measurement analysis e.g.: stenosis quantification) you are Class IIA, but:
- if such decision (like: PTCA ?) have an impact that may cause => death => Class III

If the SW provides correct information but the MO did fault actions, or other complications happened during the intervention which cause the death of the patient => is this overall thing charged to the SW classification?

Am I wrong in this kind of interpretation?
If so, any medical device software which provide any information the user can use to help on his diagnosis or treatment is automatically moved to Class III.

Is that correct?
 
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