What constitutes a Medical Device Technical File "Family?"

[Sheppi76]

What constitutes a Technical File "Family?"

When grouping devices together to create a family of products for Technical Files, rather than have a Technical File for each individual device, what constitutes a family and how is it determined if a device falls within a family?

We are creating a Technical File for a new family of Devices. These devices are products used in the mouth, but do not go past the pharynx, and they are intended for transient use. They are Class IIa devices using Rule 5 in the MDD (under invasive devices). These devices are products that connect to High Volume Evacuator systems (an active device). The intent of the device is to remove fluid from the mouth. There is no change made to the fluid, and it there is no fluid being administered into the body with this.

Now, I have been informed that they are considering adding yet another device for this line of products, however I am unsure if I can have it within the same Technical Family. The new device is a product that would connect the devices that go into the mouth to the HVE system itself, basically like a hose extension.

I have figured this new “extension” device would be Class IIa following Rule 11, now that the device itself is no longer invasive. (My only concern here is that Rule 11 is listed under “Additional rules applicable to Active Devices”. The concern is I am not positive this would be considered an active device, as the definition of an active device states…”medical devices intended to transmit energy, substances, or other elements between an active medical device and the patient, without any significant change are not considered to be active medical devices.” Although this indicates this device would not be an active device, I’m not seeing any other rule that could fit this product better.)

So in this case, I am wondering am I able to include the extension device into the same family, or would this end on in a family (and therefore Technical Family) of its own.

[sreenu927]

There is a guidance document from Health Sciences Authority (HSA) Singapore for grouping of medical devices. I certainly believe, this would help in your case, although not related to EU in specific.

See attached.

Regards,
Sreenu

[Burgmeister]

Isn't this simply an accessory to the system? Apologies if I have misunderstood your situation.

[MIREGMGR]

I too would call an extension hose an accessory, in the absence of further information leading in some other regulatory direction.

[Sheppi76]

Yes, we do consider this hose to be an accessory to the device. However since accessories are "classfied within their own right separately from the device with which it is used" I am still just addressing this as a device rather than an accessory.

I aplogize for any confusion with my question, what I am inquiring about is if there is anything defined for "what" are the requirements for constituing a family. When putting devices together for one family do the devices in that family have to have be the same Class, follow same classifiaction rule, or do they just have to be used in conjuntion together, are they supposed be be similar products by design, etc?

My opinion is that they would be in the same family, with the justification that they hose is designed to be used in conjunction with the device that goes into the mouth, I am just curious to if this is a possible justification to be used, since most of the other items I mentioned are different.

[MIREGMGR]

The informal "family" definition used by the company for which I work is: a group of devices and accessories with the same classification and the same high-level intended use, and sometimes with the same internal brand or other distinction.

[sreenu927]

From my understanding - a group of devices with accessories will form as a system.

A group of medical devices can be considered as a "Family", if they have -
- same intended use
- belong to same class
- share same design history file (DHF)
- variations may be of colour, dimensions, etc..

Eg:
- Catheters of various lengths can be grouped as a "Family" and submit ONE Technical File.
- Condoms of various colours can be grouped as a "Family"
System: Knee implant that constitutes of a ball & socket joint, various screws, rods form as "System" which is used to meet a specific intended use.

Hope this clarifies!

Sreenu