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You are here: Home Investigators Clinical investigations with medical devices (MDR) Standard research file medical devices A. Correspondence

A. Correspondence

This part of the file contains correspondence about your clinical investigation, 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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