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MDCG 2021-24 - Guidance on classification of medical devices

    https://health.ec.europa.eu/latest-updates/mdcg-2021-24-guidance-classification-medical-devices-2021-10-04_en
    MDCG 2021-24 - Guidance on classification of medical devices 1 DECEMBER 2021 mdcg_2021-24_en.pdf English (1.52 MB - PDF) Download Details Publication date 4 October 2021 Author Directorate-General for Health and Food Safety …

Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation …

What are EU MDR classification rules for …

    https://advisera.com/13485academy/blog/2021/04/22/mdr-classification-complete-guide/
    Class IIa (medium risk) – Class IIa medical device examples include surgical clamps, and this classification requires regular assessment by a notified …

MEDICAL DEVICES Guidance document …

    https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
    The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the …



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