IVD regulatory requirements for different hospital environments

R

RAGHAVENDRA A

#1
#1
Hi ,

I am a RAQA lead for one of the IVD porjects this is my first project for IVD earlier I had worked for medical devices like patient monitor systems.
As I have a predicate device where the working environment of the IVD device is general wards and emergency room of the hospital. Now we are planing to extende the intended environment to ICU and OT . So can anyone let me know do I need to consider any additional regualtory requirement for designing the same.
My product is glucometer & function is to collect the sample from the patient , analyse and provide the output parameters like ( level of glucose, hemoglobin , calcium etc present in the blood) The output would be wirelessly trasnmitted to CNS ( central nursing statin ) or to cloud and to physician.

Thank you in Advance ::thanx:
Raghavendra.A
 
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Ronen E

Ronen E

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#2
#2
Re: IVD regulatory requirements for different hospital environment

Hi,

IMO, as long as the intended use is not extended relative to the predicate (your own device, for use in general wards and emergency rooms?), there should be no additional regulatory requirements for going into ICUs or OTs. The only exception is any intention to bring the device into a sterile field (in OT, for example).

If anything, the users in ICUs and OTs are probably at least as professional and prudent as those in general wards and emergency rooms.

Cheers,
Ronen.
 
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