Hi, with reference to the new EU medical device/IVD regulations and the additional responsibilities for all economic operators, I'm not sure about the definition of Importer. The definition according to the regulations is 'importer' means any natural or legal person established within the Union that places a device from a third country on the Union market.
Would you interpret that as including the importation of devices to the UK from another EU state (Brexit notwithstanding ), or only importing devices from outside of the EU into a Union state?
Thank you.
Would you interpret that as including the importation of devices to the UK from another EU state (Brexit notwithstanding ), or only importing devices from outside of the EU into a Union state?
Thank you.