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Independent EU MDR Importer for Medical Device Manufacturers 

Luctor Medical is an independent EU medical device importer based in The Netherlands; the shipping and logistics hub of Europe. Under the EU Medical Device Regulation (MDR), effective May 2020 and EU In Vitro Diagnostic Regulation (IVDR), effective 2022, Importers take on an important role in compliance that is distinct from your EU Authorized Representative and Distributors. The Importer places devices on the market and has a crucial role in reviewing if these meet the regulatory requirements according to the MDR. Luctor Medical allows non-EU manufacturers to meet those requirements while preserving the flexibility to change distributors if needed.

Your distributor can be your importer. But what if you want to change distributors?  

The path of least resistance is to let a distributor serve as your importer of record, and they will gladly do so. But here’s the catch. Your importer’s contact information must appear on “the device or on its packaging or in a document accompanying the device.” Therefore, if you want/need to switch distributors in the future, that’s going to cause serious headaches for you because of devices already in EU distribution. Plus, you most likely have multiple distributors. You can appoint multiple importers, but bear in mind these have to be listed somewhere on the device, packaging and/or documentation. With Luctor Medical as your independent EU MDR Importer of Record, you avoid being “married” to an underperforming distributor because they also act as your EU importer. It allows you to use one name for labeling requirements and have a single central point of control. 

Tasks we perform as your EU MDR Importer of Record 

Luctor Medical is not a manufacturer or a distributor. Instead, we connect manufacturers with distributors, and act as a “third party” importer for manufacturers. Here is a partial list of what we will do as your European importer in compliance with Article 13 of the MDR and IVDR.

  • Confirm that your Declaration of Conformity meets EU MDR and IVDR requirements.
  • Double check that your labeling is EU compliant and ensure your IFU accompanies your device.
  • Ensure that each product has a Unique Device Identifier (UDI) in compliance with Article 27.
  • Register your devices in EUDAMED (once operational) in compliance with Articles 29 and 31.
  • Keep records of all your importations that were compliant
  • Report your shipments to European custom authorities (we are placing your products on the EU market)
  • Maintain a register of complaints, and immediately forward any complaints reported directly to us.
  • Perform periodic inspections of distributor facilities in compliance with Annex I and Article 13(5).

 

Contact us for a free, no-obligation proposal

If you do not have a physical location in the EU, you’ll need to appoint a medical device Importer before you can place any MDR compliant medical devices on the market. Let Luctor Medical fulfill that role for you and ensure maximum future flexibility for you. 

Contact Us

Phone

Telephone: +31 70 326 2148

Company Registration

Reg. No. 67537049