Self-test kits have been helping patients for decades, whether by monitoring diabetes with a blood glucose meter or helping women know if they are pregnant. Now, self-test kits for a range of medical conditions are available from pharmacies and other retailers and when used appropriately, can help prompt patients to seek help early from their GP or provide peace of mind, saving GP resources.
In the UK, self-test medical devices are regulated in the same way as hospital laboratory tests. Before a self-test can be legally sold, it must be CE marked and approved by an independent Notified Body, for example BSI. Manufacturers of medical diagnostics have to comply with international standards (ISO13485:2016) and present trial data to the Notified Body proving that the tests are easy to use by laypersons, give reliable results and ensuring that the patient is advised to speak with their GP before taking any action on the result.
There are many CE marked self-tests approved for sale in the UK. For example: pregnancy, ovulation, cholesterol and male fertility tests as well as blood glucose monitors and tests for coeliac disease and faecal immunochemical (FIT) bowel cancer tests. We recommend that all patients should speak with their GP or pharmacist if they are concerned about their health.
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