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Procedure File: 2012/0266(COD) | Legislative Observatory

    https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2012/0266(COD)
    COD - Ordinary legislative procedure (ex-codecision procedure) Procedure subtype Legislation Legislative instrument Regulation Amending Directive 2001/83/EC 1999/0134 (COD) Amending Regulation (EC) No 178/2002 2000/0286 (COD) Amending Regulation …

Regulation on medical devices | Legislative Train Schedule

    https://www.europarl.europa.eu/legislative-train/theme-environment-public-health-and-food-safety/file-regulation-on-medical-devices
    Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory …

Carriages preview | Legislative Train Schedule

    https://www.europarl.europa.eu/legislative-train/theme-environment-public-health-and-food-safety-envi/file-regulation-on-in-vitro-diagnostic-medical-devices
    Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory …

Legislative Observatory

    https://oeil.secure.europarl.europa.eu/oeil/home/home.do
    The Legislative Observatory offers the latest state of play on all EU legislative and non-legislative procedures going through the European Parliament. The website was …

A History of Medical Device Regulation and Oversight in …

    https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
    Authorized electronic registration of medical device firms Established the Office of Combination Products 2007: Food and Drug Administration Amendments Act (FDAAA) …

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 …

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 Regulations - Public Health

    https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
    With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC …

Medical devices - World Health Organization

    https://www.who.int/health-topics/medical-devices
    Member States recognized in World Health Assembly (WHA) resolutions WHA60.29 (2007) and WHA 67.20 (2014) that medical devices are indispensable for …

Regulation on Health Technology Assessment

    https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en
    It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on …



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