Why should the Authorized Representative sign the manufacturers Declaration of Conformity?
• The Declaration of Conformity clarifies who the European Authorized Representative is to any distributor, agent or other interested party. 8) 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 y
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?
- Why should the Authorized Representative sign the manufacturers Declaration of Conformity?
