Classification of Real-Time Thermocycler for CE Marking

I would like to know what should be the risk classification for "Realtime qPCR Thermocycler" for CE Marking. This is a device used for real time nucleic acid amplification using PCR (polymerase chain reaction).

In FDA, the device is classified as CLASS 2, under regulation number 862.2570; but I am not able to find any relevant information for CE marking purposes.

Thanks
San

A Quick Bump!

Can someone help?

Thank you very much!!

Hi San,

If it just instrument alone, then Self-Declared CE IVD.
If it is supplied with an assay, then it depends on the type of assay (Flu assay or Cancer detection assay, etc..).

Regards,
Sreenu

sreenu927 said:

Hi San,

If it just instrument alone, then Self-Declared CE IVD.
If it is supplied with an assay, then it depends on the type of assay (Flu assay or Cancer detection assay, etc..).

Regards,
Sreenu

Click to expand...

Hi Sreenu,

Thank you very much for the classification details. The assay & instrument when bundled together becomes a "List B" or "List A" CE IVD device (depending on the assay type).

But for an "instrument alone" Self-declared CE IVD scenario, what should be the validation procedures and validation documentation? Is it required to run PCR tests with 3rd party assays (Flu assays / TB / HIV assays etc)?

Looking forward for your clarification.
Thanks
San