Guidance

In vitro diagnostic medical devices used in combination

Planning and managing in vitro medical devices in combination with other devices.

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Documents

In vitro diagnostic medical devices used in combination

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Details

This Medicines and Healthcare Products Regulatory Agency (MHRA) guidance sets out:

  • information that should accompany a CE-marked IVD that is intended by the manufacturer to be used in combination with other devices and equipment
  • some product characteristics to consider for general laboratory equipment
  • actions to consider in order to verify that a combination is safe and does not impair the performance of any of the devices involved
Published 9 May 2006