Farmacy

Sep 13 2017

Guidelines for Classification of Medical Devices – CE Marking (CE Mark) for Medical Devices –

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IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking

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for Classification of

IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking

Depending on its Intended Purpose, a medical device may be classified as Class I (including Is & Im), Class IIa, IIb and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. All Class Is, Im, IIa, IIb and III medical devices require the intervention of third party: the so-called Notified Body.

    Classification of a medical device will depend upon a series of factors, including:
  • how long the device is intended to be in continuous use
  • whether or not the device is invasive or surgically invasive,
  • whether the device is implantable or active
  • whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.

The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules.

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medical devices classification guidance chart

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