Key information for UK retailers of self test kits
Saturday 1st June 2019
Dr John Rees FIBMS
Self tests are a class of medical devices that are tightly regulated in the UK, having to comply with the EU In Vitro Diagnostics Directive/Regulations (IVDD/98/79/EC) just like medical diagnostics used in hospital laboratories.
Self test diagnostics such as blood glucose meters and pregnancy tests have been available for decades, allowing individuals to take more control over their health. Similar technology is now finding its way into tests for different diseases such as coeliac disease, bowel cancer and STIs.
Used correctly and with good advice before and after purchase, self test kits can provide an accessible, low cost and reliable way to help identify a specific health issue.
Whether the outcome of a self test is a positive or negative result, individuals can be encouraged to seek further advice from their doctor earlier than they otherwise might have.
How you can keep on the right side of the law and provide the best service and products for your customers
- Customers should be advised whenever possible to speak with their pharmacist or GP if they are concerned about their symptoms
- As with any medical test result, a self test result should not be used in isolation and must always be interpreted with consideration of the individuals clinical history
- Check whether your supplier of self test kits has a certified quality assurance system for medical devices ISO13485:2016 and undergoes annual on-site inspections by independent UKAS accredited auditors
- Ensure that your products are correctly certified - the packaging of self test kits MUST display a CE mark AND the Notified Body number. Certified self test kits, such as SELFCheck, undergo independent review by scientific and clinical staff working for a Notified Body* (eg mdc, BSi, TUV) to show that the tests give reliable results and are easy to use by laypersons before they are allowed to be placed on the market
- Tests described as 'professional' means that they are only to be used by doctors, health care professionals and laboratories - it does not imply that they are superior in any way to other tests and if they only carry a CE mark without the 4 digit number, this means they are NOT approved for self test use
- Tests described as FDA approved are not legal in the UK unless they also display the CE mark AND Notified Body number on the packaging
- The instructions for use and packaging of regulated self tests have been independently reviewed and approved by a Notified Body. It is not possible to make changes to either without first gaining approval from the Notified Body
- When preparing promotional materials or copy for your website do not make any claims outside those made in the instructions for use or on the packaging
- Do not place your own company details or branding on the packaging as this would constitute own labelling and you would need approval from the original manufacturer, approval from the Notified Body and a new CE certification process
- Online retailers should make it clear on their website what the self test user should do once they have a result eg. 'Whether you have a positive or a negative result with your self test, you should always speak to your doctor if you are concerned about your symptoms.'
*A Notified Body is an independent organisation such as mdc, BSi or TUV who, on behalf of a country's Competent Authority (in the UK this is MHRA), assess medical devices including self test diagnostic devices to ensure that they meet the legal requirements for use by the general public.
If you have any questions, please feel free to contact our Quality Assurance and Regulatory Compliance Manager for advice.