In-Vitro-Diagnostic Software or Medical Device Software

[Helmut]

Hey everyone,

I've went through lots of reading material regarding medical devices and in-vitro diagnostic devices under the European MDR/IVDR but I'm not quite sure about the following:

A medical device software that creates information based on data obtained by in vitro diagnostic medical devices only, is considered an IVD software. So far, simple enough.

However, does that also apply to a software that reuses already processed data (secondary data) by an IVD device and creates new information? Let's say a laboratory analyses a sample of blood and hands out a test result. If I now put these test results into an app that aids in further diagnosis for example, would that make the app an IVD software even though no blood specimen was directly involved?

Also, from practical standpoint: Is there a tangible regulatory difference between being classified as a medical device software or as a IVD software (let's assume either Class IIb for a medical device software or Class C if it's a IVD software)?

Would love to hear your thoughts,

Cheers!

 

[shimonv]

Hi Helmut,
Regarding the first question - a secondary software processing that results in additional diagnostic data is a medical device; it's only that the input is different.

Regarding the second question - I would say that from development prospective there is not much difference; both will follow IEC 62304 standard. From regulatory standpoint, you will be required to submit different documentation in support of your medical device / IVD software. In some cases you are required to submit the results of an analytical study, in others clinical trials and in others just software V&V.

Hope it helps.

Shimon