Importer and Distribution Obligations

Importer and Distributor Obligations: What does this mean for manufacturers and how is it put into practice?

Under the EU MDR 2017/746 (MDR) and IVDR 2017/746 (IVDR), many manufacturers of medical devices (including In Vitro Diagnostics) have been left wondering what it means to appoint an importer and/or distributor and how the whole process really works.

Under both the MDR/IVDR, Articles 13, “General obligations of Importers” and 14 “, General obligations of Distributors”, lists out the responsibilities of each economic operator. Although these requirements are clearly defined, there remains many questions once an importer and/or distributor has been appointed in relation to how the physical product vs the paperwork is handled when shipping devices into the European Union (EU).

Once an importer and/or distributor have been appointed, what are the next steps? Where does the paperwork go? and how is the physical product handled?

Below describes a generalised case scenario of initially setting up an importer and distributor to supply medical devices into the EU. Processes for importers and distributors may differ as they will have their own specific internal processes for handling importer and/or distributor activities.

 

Importer

Generally, as a legal manufacturer, there will be a requirement to provide a list of documents to the importer to initially set up. These are as follows:

  • Product samples.
  • Proof of insurance – Public/Employers liability insurance.
  • Technical documentation and EU Declaration of Conformity, to confirm these exist and that storage and transportation requirements have been fulfilled.
  • Product labelling and instructions for use, including the CE mark, Unique Device Identifier (UDI), EU Authorised Representative and Importer contact details.
  • Details of any complaints, non-conformances, and recalls/withdrawals.
  • Confirmation of the manufacturers and appointed distributors registration with Eudamed (Provide Single Registration Numbers (SRN)).

A copy of the EU Authorised Representative’s certificate of registration and designation. Once the importer has been set up, there will be a requirement to provide them with the following documentation for each imported product/shipment:

  • Copies of sales orders (sales order information).
  • Photos of the product prior to shipment.
  • A packing list.
  • Delivery notes (on letter-headed paper).
  • Copies of product labelling.
  • Bill of Landing (Sea) or Waybill (Air) and Consignment note which gives details of the goods being shipped.
  • Copies of commercial sales invoices (on letter-headed paper). Avoid proforma invoices, as these can be misleading and lead to customs declarations being left uncompleted. A false declaration may stop the shipment of the product and may also lead to a fine.
  • Certificate of Free Sale (CFS) from the competent authority where the legal manufacturer is based, e.g. Medicines and Healthcare Products Regulatory Agency (MHRA). 
  • A Certificate of Origin – A document which certifies the origin of goods being exported and is issued and stamped by a Chamber of Commerce. It is required by customs in the buyer’s country to determine tariff rates and proves the origin of the goods.
  • Contact name, telephone number, full address, including country of the receiver and the Economic Operators Registration and Identification Number (EORI) for the receiver of the goods.
  • The correct value of the goods is in the correct currency, which may be shown in the form of an invoice.
  • The correct commodity code and a clear description of the goods and the quantity. A commodity code is a sequence of numbers made up of six, eight or ten digits. The commodity code determines the customs duties and other charges imposed on the goods.

It should be noted that the examples above are not exhaustive lists but more an example of information that may be requested by the importer to provide.

 

Distributor

When an order is shipped to the distributor, the following due diligence should be carried out:

  • Ensure that the device is CE marked.
  • Check that the labelling and IFU are provided in the local language (or the accepted language in that country).
  • Verify that the importer’s name is on the device/packaging or documentation.
  • Check the UDI is present on the device and/or labelling. The distributor should document a list of all UDI numbers applicable to each shipment within their system for recall purposes.
  • Ensure that the storage requirements for the device are followed in line with the manufacturer’s instructions.
  • Register any complaints or recalls to the local authorities and notified bodies on request.
  • Maintain a system to ensure ease of access to compliant information if it is requested.
  • Review the CE certificate for each product (or hold a current copy of the Declaration of conformity for lower-class devices), and if this information is not provided by the manufacturer, the distributor has the right to stop supply and notify the local competent authorities of the nonconformity.

The appointed importer and distributor can be the same organisation. In this instance, the paperwork and a physical product will be handled by that same organisation, but the requirements will remain the same.

When the appointed importer and distributor are two different organisations, copies of the requested information will be sent to the importer electronically, and the physical product will be handled by the distributor.

Below is a generalised overview of when the importer and distributor are two different organisations:

Importer and Distributer

Do you have questions that remain unanswered? LFH Regulatory can work with you to help you understand your responsibilities in relation to economic operator status and support you with any Importer/Distributor queries. Contact us today to see how we can help.

References:

Guidance on importers and distributors is available in MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746: https://health.ec.europa.eu/system/files/2021-12/mdcg_2021-27_en.pdf

Written by Hayley Claridge, Regulatory Affairs and Quality Assurance Consultant at LFH Regulatory Ltd.

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