HomeNewsDistributor Obligations - Impact of Regulation 2017/745

Distributor Obligations - Impact of Regulation 2017/745

02/10/2018





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:

REGISTRATION AND NOTIFICATION OBLIGATIONS

  • 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). 

    CONTROL OBLIGATIONS

  • 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
 

TRACEABILITY OBLIGATIONS

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

    COOPERATION OBLIGATIONS

  • 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.

OBLIGATIONS OF CONFIDENTIALITY

Regarding:
  • 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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