Representative in the European Union

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European regulations EU 2017/745 and EU 2017/746 on medical devices and in-vitro diagnostic medical devices respectively require manufacturers established outside the European Union to have a legal representative, known as a EU authorized representative, to market their products in EU countries. The role and obligations of the authorized representative are detailed in the regulations.
Drawing on its expertise in medical device regulations, MD101 can act as an authorized representative for any non-European manufacturer.

MD101 has put in place the necessary procedures to ensure the legal representative’s obligations, in accordance with EU regulations 2017/745 and 2017/746 such as:

  • Comply with obligations relating to EUDAMED registration requirements.
  • Check that the EU Declaration of Conformity and technical documentation have been established.
  • Keep a copy of the technical documentation and EU Declaration of Conformity available to authorities.
  • Ensure communication with the relevant authorities.
  • Inform the manufacturer of complaints from healthcare professionals, patients and users. Ensure communication with the relevant authorities.

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