Medical self tests are strictly regulated in the UK

Medical self tests are strictly regulated in the UK

Thursday 10th December 2020

Self-test kits can help prompt you to speak with your doctor sooner than you might have.

The UK regulations ensure that you can trust that your self-test;

  • has been independently evaluated and approved by the regulators
  • uses the same scientific principles as those used in hospital laboratories
  • is safe, giving reliable results and follow up information
  • has been designed and evaluated to be easy to use by most people
  • that the proportion of false positive and false negative results is acceptable to doctors and equivalent to hospital lab tests
  • components are high quality and fit for purpose eg. lancets and pipettes are the same as those used in hospitals
  • was developed and manufactured in laboratories certified to international standards for medical devices (ISO13485:2016)

Always check that your self-test kit has a CE mark and notified body number next to the mark. Products claiming to be FDA approved are not legal in the UK. Similarly, products claiming to be for professional use, or only have a CE mark but no notified body number, can only be used by a medical professional or hospital lab and must not be sold to the general public, as they have not been proven to be suitable for self-test use.

All SELFCheck medical self tests are assembled at our ISO13485:2016 certified UK laboratories and have been evaluated and approved by the regulators. For further information please click here