P
Does an IVD production company, that resides in one of the EU-member state, have to have a local authorised representatives in other EU-countries it sells its IVDs?
Example: our IVD company is located in the Netherlands. Do we have to have a German local authorised representative in Germany if we were to sell our IVDs there?
Do the same representative requirements also aply to research use only (RUO) medical devices?
Thank you in advance for your help.
Kind regards.
Example: our IVD company is located in the Netherlands. Do we have to have a German local authorised representative in Germany if we were to sell our IVDs there?
Do the same representative requirements also aply to research use only (RUO) medical devices?
Thank you in advance for your help.
Kind regards.