When is an Inhaler a Medical Device?

The first medical device to be certified under the MDR was an Inhaler. The BSI Group certified Novartis Inhaler Concept1 as a Class IIa under rule 20 in Sptember 2019.

This threw me a bit when I read it first as my thought was that Inhalers were viewed in Europe as a Medicinal Product. The challenge was to understand how did Concept1 operate. After some searching I found that the trade name of the device was Breezhaler®.

A Breezhaler inhaler training and demonstration pack

Then I found a demonstration video which showed that the product is not a true drug-device product. The patient must insert the drug capsule into the device and then inhales.

The critical difference perhaps between different inhalers is the requirement that to be considered a Medicinal Device that the inhaler and drug must be one single entity product. With the Concept1 device it could be deemed a reusable device and the drug element is not an integrated element of the device.

interestingly BSI used Special Rule 20 instead of Rule 14. Both identify the device as Class IIa however Rule 20 expects a device to be Class IIb if the “unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat lifethreatening conditions, in which case they are classified as class IIb.”

As can be seen in the video the patient use of the device and also the mechanism of the device may have an impact on patient safety. Interesting why they believe Class IIa was deemed sufficient.