Regulatory

SELFCHECK self test kits are manufactured using the same high quality components used in hospitals and are assembled at our UK laboratories in North Wales.

All self test medical devices are strictly regulated in the UK, and EU. Before Brexit and the UK's departure from the EU, all devices sold in the UK and throughout the EU had to comply with the requirements of the EU In-Vitro Diagnostic Directive 98/79EC (IVDD). In Europe, since May 2022, these regulations have been replaced by the In Vitro Diagnostic Regulations (IVDR) (Regulation (EU) 2017/746). In the UK, the regulations are in the process of being amended, and the new regulations will come into force on the 1st July 2023. It is widely expected that they will mirror the EU regulations, but currently the existing IVDD regulations still apply in the UK. Since January 2021, all tests sold in the UK also have to be registered with MHRA. Compliance to both the IVDD and IVDR are demonstrated by the presence of the CE mark with an associated 4 digit number on both the packaging and instructions for use. Eventually in the UK the CE mark will be replaced by the UK CA mark.

Both the IVDR and the IVDD ensure that all self test diagnostics are independently evaluated by a Notified Body such as BSi or TUV, prior to being CE marked and placed on the market. The 4 digit number associated with the CE mark denotes which Notified Body has approved the test. A Notified Body is an organisation that has been designated by an EU member state (the designating authority) to assess whether manufacturers and their medical devices meet the requirements set out in legislation. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the designating and competent authority.

Regulation of self tests is currently more rigorous than for hospital tests

There are different classes of diagnostics and these are assessed according to risk. The regulation of self test kits in the UK is more stringent than that for laboratory diagnostics, having to also ensure that the tests are easy to use by lay persons and provide relevant, reliable and easy to interpret results, as well as the required accuracy, sensitivity and specificity. Once a self test has been approved by a Notified Body and CE marked, the test may be freely sold within the UK and EU without restriction, providing the instructions for use are in the language of the country it is marketed in.

The Notified Body will check that the:

  • instructions provided are easy to follow
  • components included with the test have been validated and are fit for purpose
  • performance, safety and reliability of the device meets the requirements for its intended use
  • device is manufactured according to established international standards for medical devices (ISO13485:2016)
  • that the self test can be easily used and interpreted by laypersons

and carry out annual on-site inspections of the manufacturing facilities, quality assurance system and product technical files.

One of the key changes of the new IVDR will be to impose more responsibilities on distributors, including the requirement to have full traceability of products. One way for distributors to show compliance with the IVDR is to have an externally audited certification to ISO 13485:2016, the "gold standard" Quality Management System for Medical Devices.

All SELFCHECK products are CE marked, and assembled at our laboratories in North Wales according to a full ISO 13485:2016 quality management system, which is independently audited annually by UKAS accredited auditors to demonstrate compliance with the requirements of the IVDR. All batches of products have LOT numbers to ensure full traceability of components, and all delivery notes to trade customers contain details of lot numbers and expiry dates to ensure traceability of kits.

Technological innovations in in-vitro diagnostic techniques, as well as an effective regulatory environment, means that self test devices and particularly lateral flow devices, are evolving - becoming more reliable, easier to use and with clearer instructions and advice. Feedback from customers, opinion leaders and regulators will be important drivers for continued innovation.

Further information on our quality system, including copies of our ISO 13485:2016 certification is available from our Regulatory Manager.

JR Biomedical ISO13485 certification

JR Biomedical ISO13485 certification