Classification of MDDS in the EU

A

Agent J

#1
Good morning.

I work for a software company and one of our products qualifies as an MDDS under the FDA regulations. We are looking to begin selling in the EU and are trying to scope out the project to update our QMS. We are still early in the process and trying to familiarize ourselves with the nuances between the US and EU regulations.

The biggest question the higher-ups have is the level of effort we're going to need, which seems to hinge on if our MDDS product would be a Class I device in the EU and exempt from the stricter regulations, or not.

Does anyone have experience with this transition or know of a general guidance I can reference for the management team?
 
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J

Jerome

#3
In additon you can also consult the Borderline and Cllassification guide.
It can help if your device is not that easy to classify or if you are looking for other examples.

Hyperlink is here
 
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