January 25, 2024

UK and EU End Users Are Not Importers

Generally speaking, end users are not considered to be importers.  This is the same for the UK and the MDD/MDR alike.  For example, the European Commission’s Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR, specifically saying, in part, that in both Regulations [(EU) 2017/745 (Article 2(33)) and (EU) 2017/746 (Article 2(26)], “importer” is defined as “any natural or legal person established within the Union that places a device from a third country on the Union market”.  And therefore that, if a manufacturer established outside the EU places a device on the EU market directly to a user, in such a case there is no importer, as there is no person established within the Union placing a device from a third country.

For the UK, end users don’t generally meet the UK regulations’ trigger for “supply” or placing on the market.  If instead the end user places the devices on the market or makes them further available on the market, then UK MDR regulatory obligations would ensue.  As long as the end user only uses the devices for their own particular end use, then they aren’t supplying or placing the devices on the market.