Confirming IVD exemption from WEEE

A

ALICEqa

Hello Cove Users,

I have a question in relation to confirming IVD exemption to WEEE.

The product I am trying to confirm exemption from WEEE is an instrument which is used in conjunction with IVD consumables for testing human serum/plasma samples. The product is general class according to the current IVD Directive.

Technically the instrument should not come into contact with the patient sample, but this risk cannot be completely excluded due to the size of the area of the patient sample port and also the users accuracy at pipetting.

From the research I have done, to me it is clear that we are exempt from WEEE as the product is has potentially come into contact with infected product. I would really appreciate if any of you could confirm this?

Thanks in advance to all who can help with this query, :)
Alice
 
Mikishots

Mikishots

Trusted Information Resource
ALICEqa said:
Hello Cove Users,

I have a question in relation to confirming IVD exemption to WEEE.

The product I am trying to confirm exemption from WEEE is an instrument which is used in conjunction with IVD consumables for testing human serum/plasma samples. The product is general class according to the current IVD Directive.

Technically the instrument should not come into contact with the patient sample, but this risk cannot be completely excluded due to the size of the area of the patient sample port and also the users accuracy at pipetting.

From the research I have done, to me it is clear that we are exempt from WEEE as the product is has potentially come into contact with infected product. I would really appreciate if any of you could confirm this?

Thanks in advance to all who can help with this query, :)
Alice
Click to expand...

I'd say exempt for now, but will be recast in 2016. The exception will be very short-lived.

It's kind of a gray area, this example, because of the fact that you say it "shouldn't" come into contact with patient samples. Unless it was designed to come into contact, then....it may not be exempt. My advice would be to proceed in a manner that assumes it's not.
 
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