IVD Medical Device Authorized Representative Requirements in EU
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?
There is no requirement for any EU based company to have an EC-rep....this is only a requirement when the manufacturer is based outside of the EU. When an EC-rep is required, only one is required for all of the EU.
Re: IVD Medical Device Authorized Representative Requirements in EU
As Sreenu said, Research Use Only products are not considered as medical devices, as do not have an intended medical purpose. The reference for the RUO is clearly cited in recital 8 of the IVDD Directive 98/79/EC;
“whereas instruments, apparatus, appliances, materials or other articles, including the software which are intended to be used for research purposes, without any medical objective are not regarded as devices for performance evaluation”.
Re: IVD Medical Device Authorized Representative Requirements in EU
Hello bio subbu,
Recital 8 is not a statement about RUOs not being medical devices.
Recital 8 is a statement about performance evaluation only devices not being RUO devices.
IVD Medical Device Authorized Representative Requirements in EU
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