When is a Medical Device not a Medical Device?

As explained in “What is a Medical Device”, a device which makes a health claim (relating to diagnosis or therapy and which is not primarily by pharmaceutical means), and which is on the market in Ireland (whether or not money changes hands, whether or not it is purchased from overseas) is a Medical Device.  There will be a CE mark with a number on the device.  The number identifies a “notified body” which under the Medical Devices Directive, or Medical Device Regulations, has been designated to review the design files, device, associated literature, manufacturing processes, validation process for the device at a level of depth based on the classification of the device, which is based on the risks according to the intended use of the device.

If it doesn’t have a CE mark, classifying it as a medical device, then in terms of Irish and European law, it is not a Medical Device.

But just because a device, a wearable, an app is not designated as a “medical device”, that doesn’t mean it cannot be used to help people stay well or stay independent.

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