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For all legal manufacturers of medical devices not established in a European Member State, the device(s) may only be placed on the Union market if the manufacturer designates a sole Authorized Representative.

ALPA Medical, through its Italian office located in Brindisi, can now provide EU Representative Services as an Authorized EU Representative for Medical Devices Manufacturers outside Europe.

As your EU Rep, our responsibilities are to:

  • Execute a written contract agreement between the parties, including detailed arrangements for a change of Authorised Representative

  • Provide a Mandate Declaration for both parties to sign

  • Verify the Declaration of Conformity and Technical Documentation have been drawn up

  • Check where applicable that an appropriate conformity assessment has been implemented

  • Allow the Manufacturer to indicate the name and address of the Eu Rep office on their label(s) and IFU(s) for the devices under agreement.

  • Keep the documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of Competent Authorities (at least 10 years for Medical Devices and 15 Years for Implantable)

  • Verify that the manufacturer is complying with the registration of the Unique Device Identification according to MDR Article 27

  • Ensure that the registration of the device is performed according to MDR Article 29

  • Ensure that registration to Eudamed by the EU Representative, Manufacturer, and Importers are done according to article 31

  • Cooperate with the Competent Authorities on any preventive or corrective action in regards to adverse events, complaints, potential defect products placed on the market

  • As and when requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language determined by the Member State concerned

  • Keep the manufacturer informed of any request coming from the Competent Authorities.

  • Verify that the Competent Authorities receive the samples or is given access to the device

  • Immediately communicate to the manufacturer about complaints and reports from healthcare professionals, patients and users related to suspected incidents performed by their device.

  • Terminate the mandate if the manufacturer acts contrary to its obligations under the MDR Regulation and Contract Agreements in place

  • In case of Mandate termination, communicate to the Competent Authorities and if applicable the Notified Body that issued the certification such termination and the associated reasons.