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EUROPEAN AUTHORISED REPRESENTATIVE

In 2020, our sister company, Medicord became a European Authorised Representative (E.A.R.). E.A.R serves as a legal entity designated by non-EU manufacturers, to represent them in the EU and ensure their compliance with the European Directives.


Regulation of medical devices produced by manufactures outside of the EU, instigated the need for Authorised Representatives. Following the EU Regulation on Medical Devices 2017/745, it is required that alongside the CE mark all devices must also show their Authorised Representative.


We hold the responsibility to act as a neutral party between the competent authorities and the non-EU manufacturer. We must ensure the manufacturer complies with the conformity assessment procedure set out in the European directives which apply to the manufacture’s device. It is our responsibility to keep the notified bodies and manufacturer informed if problems or questions arise regarding the device. Please contact us find more information.

 

 

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