Article 22 EU MDR 2017/745

[Aymaneh]

Hello Folks,
we are assembling multiple medical devices (stethoscope - otoscope - tensiometre - thermometre- oxymetre - dermatoscope) all those devices are certified we combine those products in an automate which integrate a software that is embedded, the software allows the patient to make a video call with a doctor to perform digital consultation, i have 2 questions.

• Should the software be considered an accessory to medical device, without the software, the patient cannot perform the digital consultation
• Can we have the statut of manufacturer and system pack according to MDR 2017/745, if it is the case can we autocertify the software first then declare our solution to the competent authority as a system pack producer ( with the certified medical devices discussed above + the software that will be autocertified)

 

[yodon]

Does your software collect, aggregate, and/or analyze the data from the other products? Does the software retain any patient information (may not be relevant to device classification but certainly has compliance implications)? Maybe a bit more info will trigger additional discussion.

 

[DanMann]

Could you expand on "combine those products in an automate which integrate a software that is embedded"?
In what way are they "combined"? What is an "automate"? In what was is what "integrated" into what? What is the software "embedded" into?