---
kind: "section"
citation: "21 C.F.R. § 803.17"
title: "21"
number: "803.17"
heading: "What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?"
url: "https://uscodex.org/cfr/21/803.17"
---

# §803.17. What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?


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.**

## Notes

### Authority

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

### Source

Source: 79 FR 8846, Feb. 14, 2014, unless otherwise noted.