All self-test medical devices are strictly regulated in the UK and EU. SELFCHECK self-test kits are manufactured using the same high quality components used in hospitals, comply with all current UK and EU regulations, and are assembled at our UK laboratories in North Wales.
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 In Europe, since May 2022, these regulations have been replaced by the In Vitro Diagnostic Regulations (IVDR) (Regulation (EU) 2017/746), although tests approved under the IVDD are still allowed to be sold, pending the manufacturer's transition to the new regulations.
In the UK, the regulations Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) currently apply, but are in the process of being revised. The new UK regulations will come into force on the 1st of July 2024. 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 must 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, after a suitable transition period. Currently, devices can be placed on the market with either the CE mark, UKCA mark or both.
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, or an Approved Body in the UK, before being UKCA marked, and placed on the market. The 4-digit number associated with the CE/UKCA mark denotes which Notified Body/Approved Body has approved the test. A Notified Body is an independent EU 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 EU legislation. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the designating and competent authority responsible for the designation of Approved Bodies and compliance with UK regulations.
The regulation of self-testing kits 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 currently more stringent than that for laboratory diagnostics, having to also ensure that the tests have undergone user trials to prove that they 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 sold within the UK and EU, providing the instructions for use are in the language of the country it is marketed in.
The Notified Body will evaluate self-test devices to ensure that the:
- instructions provided are easy to follow by laypersons
- 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)
- self-test can be easily used and interpreted by most laypersons
- annual on-site inspections of the manufacturing facilities, quality assurance system and product technical files are carried out