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Quality defects and recalls | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls
    Assessment of reports of product quality defects. Rapid alerts and recalls. This content applies to human and veterinary medicines. The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally …

International Medical Devices Database

    https://medicaldevices.icij.org/
    International Medical Devices Database By the International Consortium of Investigative Journalists Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of …

Best Recall Practices Guidelines — Part 1 — Medical …

    https://www.sidley.com/en/insights/publications/2021/02/best-recall-practices-guideline--part-1-medical-devices
    February 2021. In this first part of a short series of articles about the recall of products in the life sciences sector from the EU and Swiss markets, we look at the Medical Devices …

European medical device recalls increase by 11% - Sedgwick

    https://www.sedgwick.com/news/2022/european-medical-device-recalls-increase-by-11
    Medical device recall increased to 719 events in this year’s second quarter, up 11% from 649 events in Q1 and 7% from 670 recalls in Q2 of 2021. Both the EU and …

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 …

Market surveillance and vigilance - Public Health

    https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en
    a medical device is unsafe and should be withdrawn from the market ('safeguard clause') a CE marking is unduly affixed to a device or missing ('wrongly affixed CE marking'). When …

Medical Devices - Sector - Public Health

    https://health.ec.europa.eu/medical-devices-sector_en
    The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …

EU Medical Device Vigilance Reporting in Europe - Emergo

    https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe
    EU medical device adverse incident and FSCA reporting process. These are the basic steps to reporting an incident in Europe: Reference MEDDEV 2.12/1 to determine the correct …

The European Union Medical Device Regulation – …

    https://eumdr.com/
    Notice to stakeholders: Status of EU-Switzerland mutual recognition agreement on medical devices. Press release 26 May 2021: announcing Stronger rules on medical devices …

Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that …



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