Medical Device PACS (Picture Archiving and Communication) - Class I or Class IIa?

[tebusse]

Greetings!

I'm having difficulty classifying our PACS in accordance with the Medical Device Directive.

Our system is indicated for the transmission, storage and viewing of medical image data, store and manipulate information associated with the image data, store and view testing results, and present a formatted presentation of the stored data and information.

According to the directive in order for a PACS to be a class IIa, the intent would have to include direct diagnosis or monitoring of vital physiological processes. While our 'Intended Use Statement' doesn't mention the word 'diagnosis', this word is mentioned in our risk analysis studies.

Should such a device be a Class I or IIa?

Regards, Tonia

[Marcelo Antunes]

If your device intended use does not fall under the medical device definition, then it's not a medical device (even if there are mentions to related stuff in other documents). That's why, for example, MDDS as defined in the US is not a medical device in the EU.

For official guidance on when your intended use does fit into the medical device definition, take a look at item 8.4 on the MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES.

[tebusse]

Marcelo,

Our device is indeed a medical device according to the definition. I've reviewed the manual on borderline classification and am still unsure of what class to place our device.

Are you able to be of any further assistance?