Bomi Group > News & Stories > The new european regulations will affect your business > Are you an importer?

Are you an importer?

How can we help?

  • We can manage your warehouse interfacing with the Manufacturer's IT system, in order to provide full and continuous traceability of the product.
  • We can actively support you with tailored IT solutions so you can interface with the manufacturer's IT system and comply with the new directives. 
  • We can provide operational and technical support for the implementation of UDI codes: including directly contacting the competent authorities, registering the products, obtaining UDI codes, filling in the  EUDAMED  database and managing future updates.

The importer has a key role in the distribution chain, and the new regulations provide that together with the agent and the manufacturer, the importer is jointly responsible for the product and the activities associated with introducing it to the market and monitoring it in compliance with the Regulations.

The importer:

  1. Before introducing a product to the market, must ensure that the CE marking and the Declaration of Conformity are present, and keep these documents on file for the period of time provided for by law for the various types of devices;
  2. Ensures that the manufacturer and the agent are correctly identified, so that the entire distribution chain that precedes them can be identified;
  3. Checks that the device is labelled correctly and that the Manufacturer has assigned the correct UDI code;
  4. Must perform a further check on the distribution chain. If it deems a device not to be compliant, it must not introduce it to the market and must inform the manufacturer and the agent;
  5. Guarantees that the storage and transport conditions do not compromise general performance and safety requirements;
  6. Has an active role with regard to monitoring and surveillance, and handling complaints and instances of non-compliance;
  7. Must always provide their NAME, DENOMINATION or REGISTERED TRADE MARK, SITE and ADDRESS on the device (either on the packaging or on the accompanying documentation) in order to be located and contacted;
  8. Must ensure that the information provided on the manufacturer's label is not covered by other labels.