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Importer of Record- What is it?

2 mins

Swiss Importer EU Importer General UK Importer

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If you export devices to the European Union, United Kingdom or Switzerland, you will need to appoint an Importer of Record. Understandably, many medical device and IVD manufacturers confuse the Importer of Record role with the regulatory compliance importer. The regulatory compliance importer is the economic operator under Article 13 of the EU MDR and IVDR  which applies to the EU, UK and Switzerland. In contrast, the Importer of Record (IOR) is the first touch point for your goods when they enter the EU, UK or Switzerland. They clear your product through Customs and pay duties/tariffs/fees.
The Importer of Record (IOR) can be:
    • Your distributor when the goods are being shipped directly to their warehouse (most likely for Ex Works shipments);
    • A Third-Party Logistics provider, often called a 3PL, acting as your fiscal representative;
    • The end user when the goods are shipped directly to them; or
    • The manufacturer itself if shipping from one company owned facility to another (ie. from a manufacturer facility in UK to another facility in Germany).

The table below displays the major differences between the Importer of Record and the regulatory compliance importer.

 

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