
10 Responsibilities of a European Authorised Representative:
- The EU Authorised Representative will register your device with the National Competent Authorities (often referred to as the NCA) before they are marketed.
- They will act as your primary contact point for all National Competent Authorities.
- The EU Authorised Representative maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
- The designated representative will have their name, address, and contact details listed on the packaging and associated materials of the device.
- Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
- Advising your company of any changes to relevant laws that will impact the marketability of your product.
- Should a member state seek to withdraw your device from the market, the EU Authorised Representative will represent your company to the European Commission.
- Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
- Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.
- The EU Authorised Representative will also carry out any post-market surveillance that is necessary.