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EUR-Lex - 32009D0886 - EN - EUR-Lex - Europa

    https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32009D0886
    The common technical specifications for in vitro diagnostic medical devices are laid down in Commission Decision 2002/364/EC (2). (2) In the interest of public health and in order to reflect technical progress including the evolution in the performance and …

Common specifications - Public Health

    https://health.ec.europa.eu/vitro-diagnostics/common-specifications_en
    Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022, covering devices detecting and/or quantifying HIV, human T-cell lymphotropic virus, …

COMMISSION - European Medicines Agency

    https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/commission-decision-7-may-2002-common-technical-specifications-vitro-diagnostic-medical-devices_en.pdf
    The technical specifications set out in the Annex to this Decision are adopted as common technical specifications for in vitro diagnostic medical devices in list A of …

In Vitro Diagnostics | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics
    In Vitro Diagnostics In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics …

Technical Specifications Series | WHO - Prequalification …

    https://extranet.who.int/pqweb/vitro-diagnostics/technical-specifications-series
    Technical Specifications Series. The Technical Specifications Series (TSS) set out the performance evaluation criteria for meeting prequalification requirements. Each TSS …

2009/886/EC: Commission Decision of 27 November …

    https://op.europa.eu/en/publication-detail/-/publication/2b2ec0f2-65c5-490e-885a-bc8b210902d8/language-en
    2009/886/EC: Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic …

Technical specifications series for submission to …

    https://apps.who.int/iris/bitstream/handle/10665/366068/9789240055865-eng.pdf?sequence=1
    common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance). ... 24. ISO …

Technical specifications for selection of …

    https://www.who.int/publications/m/item/technical-specifications-for-selection-of-essential-in-vitro-diagnostics-for-sars-cov-2
    Please refer to the latest published version: Technical specifications for selection of essential in vitro diagnostics for SARS-CoV-2. The present file includes 3 …

Guidance - MDCG endorsed documents and other guidance

    https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
    Borderline and Classification Class I Devices Clinical investigation and evaluation COVID-19 Custom-Made Devices EUDAMED European Medical Device Nomenclature (EMDN) …

Common Specifications for Class D In Vitro Diagnostic Medical …

    https://criticalcatalyst.com/common-specifications-for-class-d-in-vitro-diagnostic-medical-devices/
    Common Specifications for Class D In Vitro Diagnostic Medical Devices On 5 of July of 2022, the European Commission published the implementing Regulation …



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