CE Scope on Medical Device & Device Accessories to the Foley Catheter

[Mor628]

Hi everyone,

We sell a range Foley catheters to our customers in Australia. Some of our customers ask specifically only for spigots which is an accessory to the Foley catheter. They only want to buy the spigot on its own. This is a class 1s device.

In our CE, the scope only states Foley catheter without the word ''accessories'' or ''spigots'', but it covers the entire set (Foley catheter + accessories).

As such, our customer has had trouble registering the spigot with TGA.

What can I do to help this situation, aside from adding the word accessories to our cert during the next certification?

 

[Ronen E]

Re: CE Scope on Device & Device Accessories

Hard to provide a generic solution. This would probably require some dialogue with the TGA - you will need to start with the EC certificate and trace back to other documents from your technical file that prove that that certificate actually covers the spigots, in the configuration being exported to Australia. Someone would have to look at the actual documents and work with the specifics.

 

[Mor628]

Re: CE Scope on Device & Device Accessories

Thanks for your reply

Will probably have a chat with TGA & our NB to see how we can go about it.