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Article 14 of the Directive

Article 14 amended by the IVD

Changing to an Alternative Authorized Representative

Definition of Authorized Representative

Definition of Authorized Representative, as amended by the IVD

Distributor acting as Authorized Representative

Label, the requirements of

Need for an Authorized Representative

Reporting path between the Manufacturer and the Competent Authority

Reporting Path Flow Chart

Role of the Authorized Representative

Selecting an Authorized Representative

 

 

 

Changing to An Alternative Authorized Representative Service Provider

Will Any Additional Fees Apply