eCFR Reference Browser

---

title: "21 CFR §803.17"

source: "https://www.ecfr.gov/current/title-21/section-803.17"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "803"

part_subject: "MEDICAL DEVICE REPORTING"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "803.17"

section_subject: "What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?"

cfr_reference: "21 CFR 803.17"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

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