Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RAPS,

I'm new to device regs (particularly EU) and have recently entered the combination product space. I am planning to use a Class II nebulizer device to deliver a aqueous drug solution. The device is pending its own CE/510k approval as supported by the manufacturer. The device will be manufactured and supplied separately from the drug.

If the nebulizer manufacturer modifies the mouthpiece of the device OR modifies the rate of nebulization, either change being intended to reduce the amount of condensation on the nebulizer mouthpiece, how would this impact the CE mark status of the device? From FDA's device change 510(k) guidance it seems like either change would probably require a new 510(k), but the CE mark process and EU regs are harder for me to interpret (though maybe I haven't found the right reference).

Many thanks for your help and advice!

Hello Anon,

There could be quite varying opinions on your scenario in relation to the clinical aspects and intended purpose.  This depends on a few factors which more detail about the change needs to be understood to provide a clearer response.  Indeed there is the FDA's determination of change guidance and while there is not anything new with Europe, there is the NBOG document which many still use.  Might recommend seeking further expert advice with clinical expertise and understanding of these devices in relation to the drug products.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Mar-2022 14:37
From: Anonymous Member
Subject: Device Change Regulatory Impacts

This message was posted by a user wishing to remain anonymous

Hi RAPS,

I'm new to device regs (particularly EU) and have recently entered the combination product space. I am planning to use a Class II nebulizer device to deliver a aqueous drug solution. The device is pending its own CE/510k approval as supported by the manufacturer. The device will be manufactured and supplied separately from the drug.

If the nebulizer manufacturer modifies the mouthpiece of the device OR modifies the rate of nebulization, either change being intended to reduce the amount of condensation on the nebulizer mouthpiece, how would this impact the CE mark status of the device? From FDA's device change 510(k) guidance it seems like either change would probably require a new 510(k), but the CE mark process and EU regs are harder for me to interpret (though maybe I haven't found the right reference).

Many thanks for your help and advice!