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