Medical Device Reporting Regulation

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

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

If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports.

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

Mandatory Medical Device Reporting Requirements The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for …

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 …

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

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

§ 803.10 - Generally, what are the reporting requirements that apply to me? § 803.11 - What form should I use to submit reports of individual adverse events and …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave …

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

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

eCFR :: 21 CFR Part 803 -- Medical Device Reporting The Electronic Code of Federal Regulations Title 21 Displaying title 21, up to date as of 2/14/2023. Title 21 was last …

Mandatory Reporting Requirements: Manufacturers, …

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

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities …

Medical Device Reporting Regulation History | FDA

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

The original medical device reporting regulation that became effective on December 14, 1984, defined a manufacturer required to submit MDR reports, as any person FDA …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

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

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

Medical Device Reporting for Manufacturers | FDA

Medical Device Reporting | FDA

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

Overview of Device Regulation | FDA

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

Mandatory Reporting Requirements: Manufacturers, …

Medical Device Reporting Regulation History | FDA

Medical devices | European Medicines Agency

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