If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:
(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
(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was reportable;
(2) All medical device reports and information submitted to manufacturers and/or us;
(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.