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You are here: Home Investigators Performance studies using in-vitro diagnostics (IVDR) Standard research file IVD performance studies A. Correspondence

A. Correspondence

This part of the file contains correspondence about your performance study, such as letters and email messages.

  • A1. Cover letter
  • A2a. Authorisation from the sponsor
  • A2b. Authorisation from legal representative EU if sponsor does not hold offices within EU

See also

  • B. Forms

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