Unique situation regarding a Veterinary Medical Device and ISO 13485

[orangeisenergy]

I have a unique situation regarding veterinary medical device and ISO 13485. Here is the run down...

My company (B) is ISO 13485 certified. we make both veterinary and clinical in vitro diagnostic devices (culture media and broths).

We just partnered with another company (F) that is going to manufacture a totally new product for in vitro diagnostics in animals for us. This product that they make will have our name and label on it. We will be distributing the product. "F" is not ISO 13485 certified. What would our CB want us to do in this situation? And, is it even applicable since it is a veterinary device?

I appreciate the feedback!

 

[Ronen E]

I have a unique situation regarding veterinary medical device and ISO 13485. Here is the run down...

My company (B) is ISO 13485 certified. we make both veterinary and clinical in vitro diagnostic devices (culture media and broths).

We just partnered with another company (F) that is going to manufacture a totally new product for in vitro diagnostics in animals for us. This product that they make will have our name and label on it. We will be distributing the product. "F" is not ISO 13485 certified. What would our CB want us to do in this situation? And, is it even applicable since it is a veterinary device?

I appreciate the feedback!

In what countries are you going to distribute the new product?

 

[somashekar]

ISO 13485 defines Medical devices for Human beings.
So veternary is out of scope.
However you are still good when see your scope in lines of ISO 9001. However, these products will not be addressed in your ISO 13485 scope.
Also of importance is what Ronen E has asked you ... so that the requirements are incorporated within your ISO 9001 scope of operation as customer and applicable regulatory requirements.

 

[orangeisenergy]

In what countries are you going to distribute the new product?

In the US to start, but plans to go international (Argentina & India) just after the new year.

 

[Ronen E]

I have a unique situation regarding veterinary medical device and ISO 13485. Here is the run down...

My company (B) is ISO 13485 certified. we make both veterinary and clinical in vitro diagnostic devices (culture media and broths).

We just partnered with another company (F) that is going to manufacture a totally new product for in vitro diagnostics in animals for us. This product that they make will have our name and label on it. We will be distributing the product. "F" is not ISO 13485 certified. What would our CB want us to do in this situation? And, is it even applicable since it is a veterinary device?

I appreciate the feedback!

Hi,

Given that your initial target market is the USA, the applicable regulations are those of the USA. These include the definition for a Medical Device:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

[Emphasis added]

As you can see, in the USA the Medical Device definition is applicable to veterinary devices as well. Please also note that although the FDA recognizes ISO 13485, there is no regulatory requirement in the USA to comply with ISO 13485. In other words, how you go about implementing ISO 13485 is mostly irrelevant to your marketing clearance in the USA, and you can pretty much handle it any way you deem right, in this context. Naturally, in that narrow context it also doesn't matter whether "F" is ISO 13485 certified or not. I am almost certain that your CB is irrelevant to your regulatory clearance in the USA, so their opinion WRT that specific product almost doesn't matter.

From a more general perspective, ISO 13485 is generally meant for manufacturers of (finished) Medical Devices. According to the Medical Device definition in ISO 13485 itself (s. 3.7), a Medical Device is for human beings. This is different from the FDA's definition above. So, in the context of your veterinary devices, you are not a Medical Device manufacturer as outlined in ISO 13485, and therefore the requirements of ISO 13485 should not apply to this product line. As Somashekar already pointed out, this product line would reasonably be excluded from your ISO 13485 scope (though it is not forbidden or inconceivable to act otherwise, as the standard doesn't ban or exclude such an approach). If a product line is excluded from the scope, it should not concern the CB in connection with the certification, provided that proper segregation is practised, and the CB can be convinced that the veterinary product line operations do not jeopardize the integrity of the human medical devices QMS. In your case it sounds fairly simple because the new veterinary product is actually subcontracted in full (?) to another site and another business entity.

Cheers,
Ronen.