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

Are you a distributor?


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 distributor has a key role in the process, and the new regulations require that, together with the agent and the manufacturer, the distributor is jointly responsible for the product and its compliance, and the monitoring thereof on the market.

The distributor’s areas of competence range from making the product available on the market to commissioning the product. 

As the final link in the chain of economic operators, before making a device available on the market, the distributor must check:

  • The compliance of the marking,
  • The device documentation provided by the manufacturer,
  • That the UDI code was assigned correctly,
  • That the importers have fulfilled their legal obligations.

Furthermore, the distributor:

  1. Must ensure that the device is properly stored for the period that they are entrusted with it, in accordance with the storage and transport conditions set out by the manufacturer.
  2. Like the other economic operators, has an active role with regard to monitoring and surveillance and handling complaints and instances of non-compliance; cooperates with the manufacturer, the agent and the importer to implement corrective actions, or withdraw or recall a device.
  3. In the event of non-compliance by the manufacturer or the agent, the distributor must inform the Competent Authority, providing all of information and documentation required to prove the compliance of a device, samples and access to the device.