D.C. Mun. Regs. tit. 22, r. 22-B10410
A user facility, importer, or manufacturer shall establish and maintain MDR event files. The user shall clearly identify all MDR event files, and maintain them to facilitate timely access.
For purposes of this section, "MDR event files" are written or electronic files maintained by user facilities, importers, and manufacturers. MDR event files may incorporate references to other information (e.g., medical records, patient files, and engineering reports), in lieu of copying and maintaining duplicates in this file. MDR event files must contain:
If you are a user facility, importer, or manufacturer, you must permit any authorized DOH employee, at all reasonable times, to access, copy, and verify the records required by this section.
A user facility shall retain an MDR event file relating to an adverse event for a period of two (2) years from the date of the event. If you are a manufacturer or importer, you must retain an MDR event file relating to an adverse event for a period of two (2) years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. If the device is no longer distributed, you still must maintain MDR event files for the time periods described in this section.
If you are a device distributor, you must establish and maintain device complaint records (files). Your records must contain any incident information, including any written, electronic, or oral communication, either received or generated by you, that alleges deficiencies related to the identity (e.g., labeling), quality, durability, reliability, safety, effectiveness, or performance of a device. You must also maintain information about your evaluation of the allegations, if any, in the incident record. You must clearly identify the records as device incident records and file these records by device name. You may maintain these records in written or electronic format. You must back up any file maintained in electronic format.
A device distributor shall retain copies of the required device incident records for a period of two (2) years from the date of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater. Copies of these records shall be maintained even if a device is no longer distributed.
A device distributor shall maintain the device complaint files established under this section at the principal business establishment. A manufacturer shall maintain the file at the same location where a complaint file is maintained under Chapter 107. Any authorized DOH employee shall, at all reasonable times, have access to copy or verify the records required by this section.
A manufacturer shall maintain MDR event files as part of your complaint file, under Chapter 107, if you prominently identify these records as MDR reportable events. We will not consider your submitted MDR report to comply with this part unless you evaluate an event in accordance with the quality system requirements described in Chapter 107. You must document and maintain in your MDR event files an explanation of why you did not submit or could not obtain any information required by this part, as well as the results of your evaluation of each event.
D.C. Mun. Regs. tit. 22, r. 22-B10410