Essentials of European Medical Device Regulatory Affairs

EU Authorised Representative

• Required if Legal Manufacturer is outside community • EU Rep must be established in the Community • Acts as a contact for CA and NB in the Community instead of the manufacturer • Brexit has Impacts for UK Based Manufacturers

The Organisationfor Professionals inRegulatory Affairs

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Economic Operators

Importer, distributor and economic operators MDR Art. 2

• Importer : any natural or legal person established within the Union who places a device from a third country on the Union market • Distributor : any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market, up until the point of putting it into service • Economic operators : the manufacturer, the authorized representative, the importer, the distributor and the person responsible for regulatory requirements

The Organisationfor Professionals inRegulatory Affairs

CONFIDENTIAL. Copyright2019 Regulatory& ScientificAffairsLtd. AllRightsReserved