Guidance

Regulation of IVDs for self-testing

Guidance for notified bodies on the regulation of IVDs for self-testing.

Document

Detail

This Medicines and Healthcare products Regulatory Agency (MHRA) guidance for notified bodies covers:

  • lay studies for self-test devices
  • labelling requirements for self-test IVD devices
  • information on the instructions for use
  • conformity assessment routes for self-test devices