10409. WRITTEN MEDICAL DEVICE REPORT PROCEDURES

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). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10409