Audio Transducer as Class I Medical Device

[cjaldous]

I am trying to rationalize our device as Class I.

The device, an insert earphone, is an accessory for an audiometer. Audiometers are generally Class IIa.
The device is used inside the ear canal, is intended to touch only intact skin, and is commonly in contact for less than 1 hour (transient use).
Regardless, it seems that rule 5 would make this device Class IIa since it connects to an audiometer.

Does the fact that it is an accessory change the way I can rationalize it?

Also, the MHRA has "Auditory Testing Headphones and Accessories" (code Z172), and "Electrodes/Transducers and Accessories" (code C2) as Class I devices.

Does this strengthen my Class I rationalization?

 

[cjaldous]

Ok. I think I answered part of this myself. The following definition would seem to say that since there is more than a "remote link" between the transducer and medical use, that the transducer would be covered by 93/42 and therefore would be a Class IIa since it is invasive and connects to an audiometer. Correct?

According to MEDDEV 2.1/1 (1994)

1.2 Definition of accessory

The question whether a product is a "device" or a "accessory" has not
practical consequence. Following article 1(1) of Directive 93/42/EEC,
"accessories shall be treated as medical devices in their own right". Therefore
the main question is whether a product with a rather remote link to a
medical use can still be considered as "accessory" (article 1(2)b) and as a
matter of consequence is covered by the directive.

 

[Ronen E]

Based on the information provided, the subject earphone is class IIa or higher (rule 5 applies).

The MDD takes legal precedence over any associated guidance.

Cheers,
Ronen.