StacksVerified U.S. regulatory reference

21 CFR §803.17

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:
  1. (a)Internal systems that provide for:
    1. (1)Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
    2. (2)A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
    3. (3)Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
  2. (b)Documentation and recordkeeping requirements for:
    1. (1)Information that was evaluated to determine if an event was reportable;
    2. (2)All medical device reports and information submitted to manufacturers and/or us;
    3. (3)Any information that was evaluated for the purpose of preparing the submission of annual reports; and
    4. (4)Systems that ensure access to information that facilitates timely followup and inspection by us.