§ 804.34 - Written MDR procedures.

Device distributors shall maintain and implement written MDR procedures in the following areas:

(a) Training and education programs informing employees about obligations under this section, including how to identify and report MDR reportable events;

(b) Internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, a standardized review process/procedure for determining when an event meets the criteria for reporting under this part, and timely transmission of complete MDR's to FDA and/or manufacturers; and

(c) Documentation and recordkeeping requirements for:

(1) Information that may be the subject of an MDR;

(2) All MDR's and information submitted to FDA and manufacturers;

(3) Information that facilitates the submission of certification reports; and

(4) Systems that ensure access to information that facilitates timely followup and inspection by FDA.