What is EU authorized representative?
‘EU authorized representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.
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Responsibilities of EU authorized representative
- Responsible for contact between manufacturer and Authorities within EU
- If necessary, Support of Medical device registration
- Keep available a copy of the technical documentation
- Upon request of competent authority, Provide a copy of technical documents, CE DoC, etc.
- Provide permission to display this information on medical device labels, packaging, and user manuals
- Identify and manage the medical divece imported into the EU
- Support the Incident and Field Safety Corrective Actions (FSCA) for Vigilance
DNA TECHNOLOGIES PACIFIC - EU representative Service
