IVDD 98/79/EEC - Can I self declare?

[lenwelshlass]

Hi Guys

Looking for some help again . I have just received confirmation that a device we are looking at manufacturing will be covered as an IVD accessory. The item is inert and is designed not to touch the body and basically is a sample transporter to be used just prior to transferring into primary CE marked receptacle.

Do I need notified body sign off for an item of this nature or can I self declare?

This really is not an area I am particularly familiar with!!

Thanks for assistance in advance.

Kind Regards
Helen

 

[sreenu927]

Hi Helen,

If it is an accessory, then it must follow the classification of the instrument with which you are supplying.

Regards,
Sreenu

 

[lenwelshlass]

We wont be supplying the product stand alone but the end user will be transferring the urine into their own container. We wont necessarily know which containers they will be using.

Any advice would be appreciated.
Thanks
Helen