{"data":{"id":"us/21-cfr-803.17","jurisdiction":"us","citation":"21 CFR 803.17","heading":"What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?","body":"If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:\n(a) Internal systems that provide for:\n(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;\n(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and\n(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.\n(b) Documentation and recordkeeping requirements for:\n(1) Information that was evaluated to determine if an event was reportable;\n(2) All medical device reports and information submitted to manufacturers and/or us;\n(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and\n(4) Systems that ensure access to information that facilitates timely followup and inspection by us.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 803—MEDICAL DEVICE REPORTING","Subpart A—General Provisions"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"b2f6f0ac2fbb505fb6e906c9d24c6fa6a2859b85fa9c6ec0d1caccd5820ce92a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-803.16","next":"us/21-cfr-803.18"},"notice":"GroundRules: Original legal text. Not legal advice."}