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We are a Dutch IVD production company, and one of our products is an HLA-typing software package that is sold as CE-marked IVD-accessory in Europe.
Products that we sell outside Europe are marked RUO (Research Use Only).
We are currently in exploring possibilities for the sales/ distribution of this software package in the US. A possible distribution candidate told us that they are not allowed to sell software as RUO but only as LUO: Laboratory Use Only.
This raised the following questions within our company:
Kind regards.
Products that we sell outside Europe are marked RUO (Research Use Only).
We are currently in exploring possibilities for the sales/ distribution of this software package in the US. A possible distribution candidate told us that they are not allowed to sell software as RUO but only as LUO: Laboratory Use Only.
This raised the following questions within our company:
- What are the reasons for this explicit distinction?
- What are the differences between LUO and RUO?
- What are the implications for us as manufacturer?
- What must we do in order for us to comply with this requirement?
Kind regards.