Many types of self-tests are now available. Self-tests that have a medical purpose are in-vitro diagnostic medical devices. They can be used to diagnose a variety of conditions or to monitor a particular treatment. They can be purchased from many different sources including pharmacies and supermarkets.
While self-tests may have a role to play, they should not be relied upon on their own and it is important to remember that if you have any concerns about your health or a test result you should consult a healthcare professional.
What are self-tests?
Self-tests are healthcare products or pieces of equipment that a person uses for a medical purpose at home. They come in a variety of forms; for example, a dipstick or a test strip that you insert into a meter.
The type of sample needed to carry out the test can include blood, urine, stool or saliva. Some common examples include pregnancy tests and test kits for measuring blood sugar.
A valid medical device bears a CE mark, which indicates that it meets the basic requirements for safety and effectiveness
under European law.
On a self-testing device, there should be a four digit number below the CE mark.
Buying a medical device online
Buying a test over the internet may give you privacy and save you money, but the risks associated with the device may be greater. While genuine tests are available online, some that are advertised may pose a threat to your health.
Some tests may not work properly, may not be intended for your condition, may only be for use by healthcare professionals or may even be fake.
How to report an incident to the HPRA
You should report any unexpected problem or malfunction that may affect your health or cause or contribute to an injury to your healthcare provider, the HPRA and the manufacturer of the device.
You can report incidents to the HPRA by filling in our online user report form. If you would prefer to fill out a printed copy of the form, you can download it from our website or request a copy by phone or e-mail.
This webpage is also available as a leaflet in PDF or print format. You can request a copy by emailing email@example.com.