21 Cfr Part 803 Medical Device Reporting Mdr Regulation

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

(a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803

§ 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports? § 803.22 - What are the circumstances in which I am …

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 – Medical Device Reporting. For instructions for medical device...

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803?toc=1

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the …

Mandatory Reporting Requirements: Manufacturers, …

https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities

Medical Device Reporting for Manufacturers | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-reporting-manufacturers

Center for Devices and Radiological Health This guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses …

Medical Device Reporting | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/medical-device-reporting

The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that ensures the …

eCFR :: 21 CFR 803.18 -- What are the requirements for …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803/subpart-A/section-803.18

( 1) For purposes of this part, “MDR event files” are written or electronic files maintained by user facilities, importers, and manufacturers. MDR event files may incorporate references …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=803.3

(o) MDR reportable event (or reportable event) means: (1) An event that user facilities become aware of that reasonably suggests that a device has or may have …

Attachment C: Summary of MDR Reporting …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/attachment-c-summary-mdr-reporting-requirements

This document provides general guidance regarding the reporting of adverse events required by the Medical Device Reporting (MDR) Regulation. A. PER SE …