Feeler Gauge as a Medical Device Accessory

[shimonv]

Hi Fellows,
A company wishes to add a Feeler gauge to its list of products.
The filler gauge is is an accessory, as per MDD Article 1 (2) (b):
“‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;”

With this in mind it appears to me that the only RA approach is to add it as an accessory to an existing technical file (update risk, essential requirements, etc.).
I don't think I have the option to register it as a class Im device because, although it has a measuring function, it is not a medical device by itself.

Any thoughts/ reservations?

Thanks,
Shimon

 

[Ronen E]

Hi Fellows,
A company wishes to add a Feeler gauge to its list of products.
The filler gauge is is an accessory, as per MDD Article 1 (2) (b):
“‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;”

With this in mind it appears to me that the only RA approach is to add it as an accessory to an existing technical file (update risk, essential requirements, etc.).
I don't think I have the option to register it as a class Im device because, although it has a measuring function, it is not a medical device by itself.

Any thoughts/ reservations?

Thanks,
Shimon

Hi,

For all practical purposes, accessories are handled in the EU as devices.

If that gauge is supplied independently from any device, it needs its own registration. If it's only supplied with the device, it can be handled and registered as an integral part of the device.

Cheers,
Ronen.

 

[shimonv]

Thanks Ronen. I hear you load and clear.
I do hope it is possible to merge it with some other device because the amount of work for a stand-alone class Im accessory with clinical evaluation and all is hardly justified from a business prospective.

Have any of you seen a clinical evaluation report for a measuring device? I doubt that I will find litrature for something like that...

Cheers,
Shimon

 

[somashekar]

Thanks Ronen. I hear you load and clear.
I do hope it is possible to merge it with some other device because the amount of work for a stand-alone class Im accessory with clinical evaluation and all is hardly justified from a business prospective.

Have any of you seen a clinical evaluation report for a measuring device? I doubt that I will find litrature for something like that...

Cheers,
Shimon

Think not from your difficulty... Think from your customer and marketing requirement.
Would you ever have a situation to sell that feeler gauge alone to your customer based on his request. About the clinical evaluation, its for the purpose you determine as a medical device accessory and not for the other intended measuring purpose.....