EU equivalent to Clinical Decision Support Software

J

jackakajp

Registered
#1
#1
Hello everyone,

Hope you're all doing well. I am looking at the strategy for registering a product as CDS software in the US. However I was wondering if there is an equivalent classification in the EU?]

Thank you
 
GAGEpack - Gage & Calibration Management
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H

Horselle

Registered
#2
#2
Hi jackakajp,
In my opinion you can classify yourself as a clinical decision support unit. But you need to understand which regulation that you need to comply with.

If you are using information from IVD product you would be classified under the IVDR as a class B product. (Coming into effect in May 2022)

If you use inform mostly from medical device products you would be classified as IIa or IIb under MDR. (Already in effect)

Don’t forget to look at the MDCG documents for more information. (I cant post the link as I haven't had enough like as of yet but type it into to google and you will find it)

I hope this helps.
 
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