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

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 manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device …

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 …

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 …

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 …

Medical Device Reporting (MDR): How to …

    https://www.greenlight.guru/blog/medical-device-reporting-mdr
    On February 13, 2014, FDA published a final rule on eMDR stating manufacturers, importers, and device user facilities are all mandatory reporters and must electronically report any adverse …

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 …

New European MDCG Guidance on Medical Device Vigilance …

    https://www.emergobyul.com/news/new-european-mdcg-guidance-medical-device-vigilance-requirements
    The long-awaited Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website. MDCG 2023-3, …

Incident reporting for medical devices: …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html
    In the context of incident reporting, information on the incident refers to the circumstances required to be reported under section 59 of the Medical Device Regulations. Malfunction or …

Australian regulatory guidelines for medical devices …

    https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd
    Meet safety, performance and quality requirements for medical device manufacturers (The Essential Principles) Principle 1 - Use of medical devices not to …



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