Product Classification CE

[KhPat]

HELLO,

FDA has a guidance document regarding how MDDS (Medical Device Display System) are certified and what devices would fall under this scope, for example if a software is created just to display the parameters from FDA certified sensors, the software itself does not do any calculations or change the data from the sensor it is purely used to display this information to the user in one UI. Does anyone know if the EU have something similar to this where multiple EU approved sensors' parameters be displayed on a single EU and how would it be certified?


Look forward to hearing your thoughtful insights!

 

[shimonv]

Hi @KhPat ,
The EU has something similar to MDDS. Have a look at classification rule 11 in the MDR:

"Rule 11

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."

Shimon

 

[KhPat]

Hi @shimonv

Thank you very much for this, I absolutely forgot about Rule 11 regarding "all other software is classified as Class I". I shall be in touch with our EC Rep regarding this.

For FDA i was looking for information on how they manage this, is there an application to submit for MDDS, I was unable to find this information in the guidance document they provided.

 

[dgrainger]

Does the software qualify as an accessory to the 'sensor' or is it a component of a new device?

 

[shimonv]

Hi @shimonv

Thank you very much for this, I absolutely forgot about Rule 11 regarding "all other software is classified as Class I". I shall be in touch with our EC Rep regarding this.

For FDA i was looking for information on how they manage this, is there an application to submit for MDDS, I was unable to find this information in the guidance document they provided.

Medical Device Data System is a class I device and exempt from 510(k) application.
Have a look at the following link:
Product Classification

Cheers,
Shimon

 

[KhPat]

Does the software qualify as an accessory to the 'sensor' or is it a component of a new device?

So this would be a Class I device, which uses CE approved sensors to just display those parameters, the software does not conduct any calculations its just purely to display the parameters into one UI, similar to what MDDS (FDA) is.