In vitro diagnostic medical devices used in combination

This publication was withdrawn on 10 September 2015

This item, including the PDF, has been withdrawn so the guidance is no longer valid.

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



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