HomeNewsDistributor Obligations - Impact of Regulation 2017/745

Distributor Obligations - Impact of Regulation 2017/745


According to Article 2 (34) of the new Medical Devices Regulation, a distributor is considered as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;" 

The distributor must respect many obligations that the regulation details in several points:


  • Register with the competent authorities according to the member states (not mandatory throughout the EU).
  • Inform the manufacturer (or authorised representative and importer) and the competent authority in case of:
  • • Suspicion of non-compliance or falsification.
    • Non-compliance (the distributor does not provide the device)
    • Complaint or report of a health professional, patient or user related or likely to be related to the device (a claims register must be maintained). 


  • The device is CE marked and the EU declaration of conformity of the device has been established.*
  • The device must be provided with the information that the manufacturer must give (label, instructions for use). *
  • The information (name, company name, registered office, address) concerning the importer is present on the device, on its packaging or in a supplementary document.*
  • The manufacturer has assigned UDI code.
  • Storage or transport conditions are in accordance with the conditions set by the manufacturer.
      * = possible sampling


  • Keep and save (preferably by electronic means), UDI code of the class II implantable devices that he provided or was provided.


  • Cooperate with the competent authorities to:
• Eliminate or ease the risks associated with a device provided by the distributor.
• Provide documentation, information, samples or access to a device, or perform inspections at its premises.

  • Take appropriate corrective action to bring the device into compliance with the requirements of the regulation following the identification of an unacceptable or not, risk to health or safety.


  • Personal data,
  • Confidential business information and business secrets, including intellectual property rights, unless the public interest justifies the disclosure,
  • The application of the Regulation, in particular as regards inspections, investigations or audits.

These obligations have been defined in the new medical devices regulation that NEOMED Services has detailed in a previous article



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