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Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical...

Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    A medical device may contain an ancillary medicinal substance to support the proper functioning of the device. These products fall under the medical devices legislation …

CE Marking for Medical Devices [Step-by-Step Guide]

    https://www.simplerqms.com/ce-marking-for-medical-devices/

    CE Marking for Medical Devices - Intertek

      https://www.intertek.com/medical/ce-marking/
      Classify your product - Class I, IIa, IIb, and III according to the classification rules in Annex IX of the MDD: Class I. Devices with low risk such as external patient support products. …



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