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Labelling

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For Medical Device and in vitro diagnostic medical devices, the label or outer packaging or instructions for use shall contain the name and the address of the authorized representative where the manufacturer does not have a registered place of business in the Community.

European Authorised Representative​

EC REP

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Where a manufacturer who places a device on the market under his own name does not have a registered place of business in EU, he shall designate An Authorized Representative.

An "Authorized Representative" under the Medical Devices Directives, means:

Any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by
authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this directive. 

The appointment of an authorized representative does not change the responsibilities of the manufacturer.

The European Representative Role  


  •  Act as your official correspondent for all National Competent Authorities.
  • Submit Notification for your class I medical devices.
  •  Where required by national regulation, Register your medical devices with the National Competent Authorities.
  •  Provide you with authorization to place our EU Authorised Representative details on your labelling and packaging.
  •   Coordinate the communication between you and the National Competent Authorities.
  •   Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.
  •   Maintain the Technical File of your medical devices to be available for inspection by the European Competent Authorities.
  •   We will exercise diligence to maintain the confidentiality of your Intellectual Property.