Hi all, apologies if this has been done to death but can anyone offer any clarification on a business based in the UK acting as an Importer of a medical device from a third country?
The definition of an Importer in the MDR states: "importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market: "
Now that the UK has left the Union and is considered a third country for MDR, is it possible for us to still act as an importer? What is the role if we buy from a third country and sell back into the EU; USA to UK to Germany for example? I literally can't find a thing that clearly explains or clarifies the Importer role when buying third country to third country and then exporting back in to the EU! I know this wouldn't be an issue if we were only supplying the purchased goods within the UK but we export back into the EU so the goods we buy must be MDR compliant and our role defined as if we are/can be classed as an importer am I right in thinking we then need an EU Authorised Rep and Eudamed registration? Anyone have any experience of this or have any useful links/contacts for advisors?
The definition of an Importer in the MDR states: "importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market: "
Now that the UK has left the Union and is considered a third country for MDR, is it possible for us to still act as an importer? What is the role if we buy from a third country and sell back into the EU; USA to UK to Germany for example? I literally can't find a thing that clearly explains or clarifies the Importer role when buying third country to third country and then exporting back in to the EU! I know this wouldn't be an issue if we were only supplying the purchased goods within the UK but we export back into the EU so the goods we buy must be MDR compliant and our role defined as if we are/can be classed as an importer am I right in thinking we then need an EU Authorised Rep and Eudamed registration? Anyone have any experience of this or have any useful links/contacts for advisors?