Greece Authorized Representative

When manufacturer of a medical device is established outside of European union manufacturer needs to appoint an authorized representative to place medical device in one of the member states.

Introduction

An Authorized Representative is any person naturally or legally established in the European Community who can act on the behalf of manufacturer.

A written mandate/letter designating an authorized representative for medical device manufacturer is mandatory. The authorized representative must provide a copy of the mandate to the competent authority when requested.

Task performed by Authorized Representative

The authorized representative shall perform the following tasks specified in the agreement between it and the manufacturer.

• Representing the Manufacturer: Act as a liaison between the manufacturer, the European Commission, authorities, and notified bodies to ensure smooth regulatory compliance.
• EU Declaration and Technical Documentation Verification: Confirm that the EU declaration of conformity and the device’s technical documentation are current, and that the manufacturer has followed the proper conformity assessment process.
• Document Accessibility: Maintain copies of the technical documentation, EU declaration of conformity, and relevant certificates for easy access and inspection by the European Competent Authority.
• Device Registration: Register devices with national databases before they enter the market, ensuring a smooth launch and adherence to regulations.
• Conformity Demonstration: Provide the necessary information and documentation to showcase the device’s compliance when requested by a competent authority, using the official language of the concerned Member State.
• Forwarding Requests and Ensuring Access: Pass on any requests from a competent authority for samples or access to a device, ensuring that the authority receives the samples or access needed.
• Collaboration on Risk Mitigation: Work with competent authorities on preventive or corrective actions to minimize risks associated with devices.
• Immediate Notification of Issues: Promptly inform the manufacturer of any complaints or reports from healthcare professionals, patients, and users regarding suspected device-related incidents.
• Regulatory Compliance and Advising: Ensure the device remain compliant with updated regulations and advise the manufacturer on any changes to European regulations.
• Mandate Termination: Terminate the mandate if the manufacturer fails tofulfill its obligations under this regulation.