A "sieve" inside a pot for seperating Tissues from Fluids - IVD or not?

[rob73]

We are looking at designing an accesory to another of our devices, it will be basically a "sieve" inside a pot for seperating tissues from fluids. These tissues may or may not be used later for diagnosis or biopsy and would be stored in the pot. Would the device fall under IVD or MDD?

 

[Ronen E]

We are looking at designing an accesory to another of our devices, it will be basically a "sieve" inside a pot for seperating tissues from fluids. These tissues may or may not be used later for diagnosis or biopsy and would be stored in the pot. Would the device fall under IVD or MDD?

Hi,

The IVD devices directive, article 1, includes the following:

(b) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

(c) ‘accessory’ means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.

(...)

Sounds like this sieve is either an IVD device or an IVD accessory.

Cheers,
Ronen.

 

[rob73]

Ronen
Many thanks .
I guessed as much from reading 93/42 MDD, my boss however disagrees and insists that the product is a medical device 93/42EEC not IVD.
I am going to download 98/79EC and have a good read so I understand what the impact could be.
Rob

 

[Ronen E]

Ronen
Many thanks .
I guessed as much from reading 93/42 MDD, my boss however disagrees and insists that the product is a medical device 93/42EEC not IVD.
I am going to download 98/79EC and have a good read so I understand what the impact could be.
Rob

Hmmm... Does your boss have an argument besides "It is the boss's right to be the boss"?...

Maybe worth a little friendly chat with your NB.

Good luck anyway,
Ronen.

 

[Ron Boumans]

Hr Rob73,

Just saw your question of 14th August 2012.

First question: what is the intended use for the sieve? As you write, this device is only intended for separating tissues from fluids. This step on its own is not a diagnostic step. It is also not a standard part of a larger diagnostic procedure. So I don't see this as an in-vitro diagnostic device.

Second question: is it a medical device? Yes! This is a device intended to change a fluid taken from the human body for (possibly) diagnostic use. This falls within the definition of a medical device. For once, your boss is right!

Third question: classification? Go for Rule 3: modification of fluids: Class IIb.

 

[rob73]

Ron
Thanks for the reply, we have gone down the medical device route as the device falls into the "specimen recepticle" description. We think that rule 3 would not apply as we are not modifying the biological or chemical composition of the fluid, and as the fluid will be disposed and not intended for adminstration, rule 2 would not apply either, so we are prelimnarily classing the device as class 1. We are going to confirm this with our NB.

 

[Ron Boumans]

Dear Ron73,

I must appologize, I made a mistake. I had an other look at the legislation and the MEDDEV's and now I have to correct myself.

The pot in which you store the tissue is considered to be specimen receptacle, and therefore it should be considered to be an IVD. The sieve is specificly intended to be used together with the pot, in order to separate the tissues from the fluids. Therefore the sieve should be considered to be an accessory to an IVD.

The IVD directive is therefore applicable.

Let me know what the notified body thinks of this.