21 CFR § 803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was reportable;
(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and
(4) Systems that ensure access to information that facilitates timely followup and inspection by us.
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