Providing accompanying Medical Device Accessories

I have seen a few threads about kits, but I haven't been able to find any information about providing accompanying accessories here on the Cove, nor in the regulations. Our marketing group is proposing that we provide our customers an off the shelf, CE Marked device that is commonly used together with our CE Marked device. We would not be packaging/kitting it with our product, just proving it in it's original packaging/labeling along with orders for our product.

Can anyone point me in the direction of applicable regulations if we were to pursue this? It's clear we would need applicable quality systems in place for purchasing, storage, shipping, etc., but are there regulatory or legal considerations?

Thanks in advance for your help!!

You should probably look at Article 12 of the directive relating to system and procedure packs

Although you say that it wouldn't be packaged/kitted together, I imagine if you provide it in any way with your product intending it to be used together you would be hard pushed not to describe it as a system pack - you have just stated that you intend for them to be used together!

Regardless, provided that all of the products are already CE marked then this shouldn't cause any problem - you would just need to put a declaration together to say that they are compatible, have been put together with a suitable level of control and that you proivde all relevent information. Additionally you should notify your competent authority that you are placing a pack on the market.

Mickey999 said:

I have seen a few threads about kits, but I haven't been able to find any information about providing accompanying accessories here on the Cove, nor in the regulations. Our marketing group is proposing that we provide our customers an off the shelf, CE Marked device that is commonly used together with our CE Marked device. We would not be packaging/kitting it with our product, just proving it in it's original packaging/labeling along with orders for our product.

Can anyone point me in the direction of applicable regulations if we were to pursue this? It's clear we would need applicable quality systems in place for purchasing, storage, shipping, etc., but are there regulatory or legal considerations?

Thanks in advance for your help!!

Click to expand...

If you're talking about a sterilization tray or case -
Sterilization trays and cases are FDA Class 1, product code FSM, generally exempt from pre-market notification. To CE mark them they would typically be Annex VII, self declared in the MDD. That's what my company does.

if it's a wrap/container meant to hold sterilization for a period of time you're moving into Class 2.