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

---
identifier: "/us/cfr/t21/s803.17"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?"
title_number: 21
title_name: "Food and Drugs"
section_number: "803.17"
section_name: "What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "803"
part_name: "MEDICAL DEVICE REPORTING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 352, 360, 360i, 360j, 371, 374."
regulatory_source: "79 FR 8846, Feb. 14, 2014, unless otherwise noted."
cfr_part: "803"
---


# 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.