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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 repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …

Medical Devices - EUDAMED - Public Health

    https://health.ec.europa.eu/medical-devices-eudamed_en
    EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors …

European Commission - Legal Service - Recasting of …

    https://ec.europa.eu/dgs/legal_service/recasting_en.htm
    Recasting is like codification in that is brings together in a single new act a legislative act and all the amendments made to it. The new act passes through the full …

Recast of the Medical Devices Directives - European …

    https://ec.europa.eu/health/archive/ph_systems/docs/ev_20080617_co03_en.pdf
    Recast of Medical Devices Directives • Simplification exercise (MDD and AIMD and Blood Directives) • Coherence and uniform application of the key …

The European Union Medical Device Regulation – …

    https://eumdr.com/
    Press release 26 May 2021: announcing Stronger rules on medical devices (EU MDR) have entered into application. Publication of MDCG 2021-8 Clinical investigation …

RECAST OF THE MEDICAL DEVICES …

    https://ec.europa.eu/docsroom/documents/12983/attachments/37/translations/en/renditions/native
    Recast of the Medical Devices Directives Unit ENTR F/3, Cosmetics and Medical Devices SPECTARIS is the German trade association representing the National and International …

EU Recast of the Medical Device Directives: The Rocky …

    https://www.cromsource.com/wp-content/uploads/2012/12/EU-Recast-of-the-Medical-Device-Directives.pdf
    The reprocessing of devicesencompasses various activities to ensure that a medical device can be safely reused, ranging from decontamination, sterilisation, cleaning, disassembly, …

Recast of the Medical Device Directives - CROMSOURCE

    http://www.cromsource.com/wp-content/uploads/2012/12/EU-Recast-of-the-Medical-Device-Directives.pdf
    Recast of the Medical Device Directives - CROMSOURCE

RECAST OF THE MEDICAL DEVICES …

    https://ec.europa.eu/docsroom/documents/12983/attachments/16/translations/en/renditions/native
    Recasting into a single Directive will be surely beneficial to industry and to authorities, unless the new larger and wider-application Directive would need to be …

EPF the Recast of the Medical Devices Directives - eu …

    https://www.eu-patient.eu/globalassets/policy/medicaldevices/final_epf_response_consultation_medical_devices.pdf
    EPF’s response to European Commission’s public consultation on the Recast of the Medical Devices Directives September 2008 The European Patients Forum (EPF) welcomes the …



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