Which of the Authorized Representatives essential duties are listed in the Medical Device Directive and what should we ask for in addition?
• Essential Duties required by Law: • Authorization to place its name, address, phone number on your device labels etc. • Acting as your primary contact point for the EU Authorities. • Registering of your Risk Class I devices with the Authorities before they are marketed. • Keeping your technical file documentation ready and available for the European Competent Authorities. • Protecting your documentation confidentiality because they are authorized to show them to the Competent Authorities only. • Notification of serious device incidents to the Competent Authorities Additional services you should ask for: • Assistance with technical file documentation including examples of procedures • Simplification of the Risk Analysis • Co-signing of the Declaration of Conformity • Annual review of your technical file • On-site visits • Notification of changes and amendments to the Medical Device Directive that affect your device(s). 7) Why should the Authorized Representative sign the manufacturer’
Related Questions
- Which of the Authorized Representatives essential duties are listed in the Medical Device Directive and what should we ask for in addition?
- Why must a non-EU manufacture of medical device appoint a European Authorized Representative?
- Why must the manufactures of medical devices designate an EU/EC Authorized Representative?
