What does the Authorized Representative expect from us, the manufacturer?
• Device compliance with the Medical Device Directive requirements. • Placing of your technical documentation in its trust. • Immediate notification of device incidents. • Full cooperation with requests from the Competent Authorities • Product Liability Insurance coverage that includes the EU. • Indemnification of product liability. 9) Why do we need to place a partial technical file with our Authorized Representative in Europe? • To enable the Authorized Representative to respond to inquiries from the Competent Authorities within an allocated time period. 10) How do we keep this technical file up to date? • An Authorized Representative should, at a minimum, provide you with an annual review of your technical file and remind you what to update. You should have access to your documentation in Europe when traveling for a personal review. Your Authorized Representative should visit your facility at regular intervals and assist you with the update. 11) Is all the information that we place
Related Questions
- Why do Authorized Representative agreements include a penalty clause in case of a contractual violation by the manufacturer?
- What are the Authorized Representatives obligations and liabilities if the manufacturers devices are not in compliance?
- What does the Authorized Representative expect from us, the manufacturer?
