What are the Authorized Representatives obligations and liabilities if the manufacturers devices are not in compliance?
• The Authorized Representative and the manufacturer are both obliged to end the infringement under conditions imposed by the member state such as: a letter of warning, penalty, sales ban etc.. Plus the producer i.e. manufacturer and other entity placing its name on the device, is liable for damages caused by defect devices. This is outlined in the product liability directive. 13) Is product liability covered by the Authorized Representative agreement? • The product liability directive refers to any entity placing its name on the device. The medical device directive requires that the manufacturer plus the Authorized Representative names be printed on the device label, with the result that both parties are held liable. To prevent duplication of liability insurance for the same device the Authorized Representative becomes an additional insured under the manufacturer’s worldwide policy. 14) Why do Authorized Representative agreements include a penalty clause in case of a contractual viola
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 must the manufactures of medical devices designate an EU/EC Authorized Representative?
