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How Your Medical Device Importer of Record Differs from Your Regulatory Compliance Importer

Updated: Mar 29


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 get confused about this role and how it differs from the regulatory compliance importer that is required under EU, UK and Swiss medical device and IVD regulations. To be more specific, the economic operator under Article 13 of the EU MDR and IVDR.


An easy way to think about it is that the Importer of Record (IOR) is the customs related, first touch point for your goods when they enter any European Union member state, the United Kingdom or Switzerland. They clear your product through Customs and pay duties/tariffs/fees. The IOR might be:


  • Your distributor if 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 if goods are shipped directly to them; or

  • The manufacturer itself if shipping from one company owned facility to another (example: from a manufacturer facility in UK to another in Germany).

Comparing the Importer of Record to the Regulatory Compliance Importer

Role and Duties of the Importer

Importer of Record (EU, UK and Switzerland)

Regulatory Compliance Importer

(EU, UK and Switzerland)

Takes ownership of goods at time of import

Yes

No

Requires EORI (Economic Operator Registration and Identification) number or VAT number

Yes

No

Completes Customs entry documents and pays clearance duties/tariffs

Yes

No

Assumes legal responsibility for initial classification and valuing of goods

Yes

No

Obtains import permits, as needed

Yes

No

Name appears on shipping paperwork

Yes

No

Handles/warehouses products, if needed

Yes

No

Name appears on product labeling or document accompanying the device (e.g. packing slip)

No

CH – Yes EU – Yes UK – No

Requires Single Registration Number (SRN)

No

Yes

Checks compliance with national medical device regulations

No

Yes

Legal liability for compliance with national medical device regulations

No

Yes

Verifies device labeling compliance with national laws

No

Yes

Verify that storage and handling regulatory requirements have been met

No

Yes

Maintains list of product complaints

No

Yes

Reports serious incidents or risks to relevant competent (regulatory) authority

No

Yes

Maintains traceability of devices in the supply chain

No

Yes

Hire a professional to handle importing responsibilities

MedEnvoy is a professional, third-party provider of regulatory compliance importer services for medical device and IVD manufacturers. We help you comply with EU MDR and IVDR, the UK MDR regulations and Swiss regulations.

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