I am looking for help in classifing our IVD in Brazil.
We produce automation systems for hospital laboratories. The automation moves the blood/urine samples and send them to the partner's analyzers.
The samples can be centrifuged, decapped , aliquoted and after the analysis they can be recapped and stored in a big fridge (these are all our product functionalities). We do not perform any analysis, our partner's analyzers perform the analysis.
Here is our intended use:
It is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.
The system consolidates multiple Analytical instruments into a unified workstation
We have already received an advice about the classification:
-Pre-Analytical and Post-Analytical modules which can be registered together into one family, Class I device in Rule 12, “Cadastro”. ( this device does not require INMETRO and/or GMP)
Do you think that this classification is correct?
If so, which are the next steps?
thanks for helping!