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View Full Version : CE Marking Process - Obligations of an Authorized Representative


marcofognog
16th April 2008, 10:41 AM
Hello,

does somebody know what are the obligations of an autohrized representative? what does it do?
I would like to take a look in a authoized representation contract, ou a model of it. I think all the rights and obligations must be in there, ok?

I´d be gratefull if someone could help.

Thanks.

SilverHawk
16th April 2008, 12:05 PM
This is not exhautive but you can work out more on this as follows :-

• Coordinates the implementation of the post market activities on Post Market Feedback; Product Recall; Adverse Incident Report and Customer Complaint Handling;
• Responsible in receiving Customer Complaints from customers themselves or from distributors, and feedback information into Corrective Action System;
• Responsible for holding a copy of Technical File at site office and to be provided to a Competent Authority on request and relevant important issues to be addressed.
• Responsible to act and to be addressed by Competent authorities and Notified bodies in the EU with regard to communicating verbally or in writing with Competent authorities.
• Responsible for the activities of product recall once authorised by the CEO;
• Initiates appropriate corrective and preventive action to rectify any potential discrepancies and non-compliances;