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Radiology software Class I exemption

#1
Hi,
my company develops patient database software , for radiology images with translation function, and also marks suspecious areas of the image, and uses PACS. I am a bit confused if it is eligible for an exemption. The product does not count as a medical device in Europe.

Could you help me find out if it is an exemption?
 
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dgrainger

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#2
Given the diagnostic function claimed - "marks suspicious areas of the image" - it appears to qualify as a medical device.

You can apply to individual competent authorities for a COVID related exemption.
 

Tidge

Trusted Information Resource
#4
Hi,
my company develops patient database software , for radiology images with translation function, and also marks suspecious areas of the image, and uses PACS. I am a bit confused if it is eligible for an exemption. The product does not count as a medical device in Europe.

Could you help me find out if it is an exemption?
The database functions are very unlikely to qualify as a medical device. The diagnostic functions make it sound very much like a medical device. The medical device industry is (appropriately) extremely reliant on risk management for medical devices. Folks who are not familiar with medical device risk management may not recognize potential areas of risk, so it may be worthwhile to perform this exercise with folks who are familiar with the specific application.

The only caveat I will offer on my own assessment is this: In this area, the pendulum swings back-and-forth. The 'big data' intrusion (my words, other opinions may vary) into healthcare space has clouded this issue. Historically, the area of AI assistance in diagnostic image interpretation flares up and then dies down. I can imagine the reasons for both (positive and negative) drivers, but it would involve speculation on my part.
 
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