FDAnews Device Daily Bulletin

UK Provides Guidance for Notified Bodies on IVD Self-Tests

Aug. 22, 2012
Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies. The final guidance, published July 6, discusses how notified bodies should assess lay user studies of self-test in vitro diagnostic (IVD) devices, labeling requirements and other information related to a device’s instructions for use (IFU).
International Medical Device Regulatory Monitor