10409 WRITTEN MEDICAL DEVICE REPORT PROCEDURES

10409.1 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 Medical Device Report (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 the Department, or to both if required; and

(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 or the Department;

(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 follow-up and inspection by the Department.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).