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Medical Devices - Sector - Public Health

    https://health.ec.europa.eu/medical-devices-sector_en
    Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023. News announcement. 12 January 2023.

Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

Medical Devices - EUDAMED - Public Health

    https://health.ec.europa.eu/medical-devices-eudamed_en
    On 1 December 2020 the European Commission has made available the Actor registration module.It is the first of six EUDAMED modules.EUDAMED… UDI/Devices registration …

Medical Devices - New regulations - Public Health

    https://health.ec.europa.eu/medical-devices-new-regulations_en
    Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746. News …

Medical Devices - Sector - Latest updates - Public Health

    https://health.ec.europa.eu/medical-devices-sector/latest-updates_en
    Medical Devices - Sector - Latest updates. MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to …

Public Health: medical devices - ec.europa.eu

    https://ec.europa.eu/commission/presscorner/detail/en/ip_23_23/smo
    Public health: more time to certify medical devices to mitigate risks of shortages. Highlights, press releases and speeches ...

provisions for certain medical devices and in vitro diagnostic …

    https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf
    Source: European Commission, based on data provided by 30 notified bodies in October 2022. This is in stark contrast to 21,376 valid certificates issued under Council Directive …

The European Union Medical Device Regulation – …

    https://eumdr.com/
    The European Commission published MDCG 2019-7, guidance on the person responsible for regulatory compliance (PRRC). The European Commission published …

MDR transition delay approved by EU Parliament and Council

    https://www.medicaldesignandoutsourcing.com/mdr-transition-delay-approved-eu-parliament-council/
    2 days ago · The move gives medical device manufacturers more time to certify their devices under the new MDR rules. ... custom-made devices to May 2026. The …

European Parliament votes to extend MDR transition period

    https://www.raps.org/news-and-articles/news-articles/2023/2/european-parliament-votes-to-extend-mdr-transition
    2 days ago · The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving …



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