The European Union requires all foreign firms would like to market medical products in the EU to appoint an Authorized Representative to be responsible towards the European Authorities for all European Regulatory Affairs.
The European Representative address must appear on the product label, or the outer packaging, or instructions for use. Qsite can provide these services.
- Notify your product to the Competent Authority in order to apply for CE-Marking
- Provide a European Business Address as required by the Directive
- Maintain the technical documentation for routine inspection by the European Competent Authorities
- Ensure the communications between the European Competent Authorities and the manufacturer
- Observe the manufacturer's compliance with the European Directive
- Supply the competent authority with a Medical Device Report (MDR) as required