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Manufacturers

EU Manufacturer

Economic Operator Requirement Procedure

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Identify Importer, Distributor

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Identify Role for the Company

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Product Label Responsibilities

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Facility Requirements

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Contract / Agreement

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EUDAMED Registration

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Traceability

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Train Distributors on Responsibilities

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Closed Loop Post Market Surveillance

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Setup Receiving Inspection Requirements

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Evaluate/Monitor Distributor

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QMS Transition from MDD to MDR

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Non-EU Manufacturer

Economic Operator Requirement Procedure

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Identify Authorized Representative, Importer, Distributor

Section description goes here

Identify Role for the Company

Section description goes here

Product Label Responsibilities

Section description goes here

Facility Requirements

Section description goes here

Contract / Agreement

Section description goes here

EUDAMED Registration

Section description goes here

Traceability

Section description goes here

Train Importers and Distributors on Responsibilities

Section description goes here

Closed Loop Post Market Surveillance

Section description goes here

Setup Receiving Inspection Requirements

Section description goes here

Evaluate/Monitor Distributor

Section description goes here

QMS Transition from MDD to MDR

Section description goes here

Additional Documents

Additional Documents 1

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Additional Documents 2

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Additional Documents 3

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Additional Documents 4

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