Our company is currently developing software that calculates the required dioptric power of an intraocular lens. It is provided as service on a webpage. It is not strictly required to use this specific software in combination with our intraocular lens. Surgeons can use alternatively methods as well.
MDR says the following about classification of software:
Annex XVIII, chapter II, 3.3 - Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right
and in Chapter III, 6.3 - Software intended 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 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 is classified as class I.
It is clearly not a type of software that drives the devices nor that it influences the use of the device. It does provide information that can be used in therapeutic decision taking (which dioptric power do I need to select). I therefore believe that it is a class IIA device.
But I do know thats several other IOL manufacturers did classify their online calculators as Class 1 under MDD. The classification criteria between MDD and MDR do not differ significantly. Which arguments can be made to classify it as a Class 1 device?
MDR says the following about classification of software:
Annex XVIII, chapter II, 3.3 - Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right
and in Chapter III, 6.3 - Software intended 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 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 is classified as class I.
It is clearly not a type of software that drives the devices nor that it influences the use of the device. It does provide information that can be used in therapeutic decision taking (which dioptric power do I need to select). I therefore believe that it is a class IIA device.
But I do know thats several other IOL manufacturers did classify their online calculators as Class 1 under MDD. The classification criteria between MDD and MDR do not differ significantly. Which arguments can be made to classify it as a Class 1 device?
