Regulatory

SELFCheck self test kits are manufactured using the same high quality components used in hospitals and assembled at our UK laboratories according to an externally audited quality assurance system for medical devices (ISO13485:2016).

All self test medical devices are strictly regulated in the UK, having to comply with the requirements of the EU In-Vitro Diagnostic Directive 98/79EC (IVDD). All diagnostic tests sold in the UK and throughout the EU must comply with these regulations and carry the CE mark to show compliance. There are different classes of diagnostics and these are assessed according to risk.

The IVDD ensures 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.

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. Following Brexit, from 1st January 2021, the regulation of IVDs in the UK will remain largely unchanged. Whilst EU members will be transitioning to the IVDR, the regulation of IVDs in the UK will continue to be governed by the IVDD 98/79EC.

Regulation of self tests is more rigorous than for hospital tests

The regulation of self test kits in the UK is more stringent than laboratory diagnostics to ensure that the tests are easy to use by lay persons and provide relevant, reliable and easy to interpret results. Once a self test has been approved by a Notified Body and CE marked, the test may be freely sold within the 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)
  • 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.

The IVDD is currently undergoing transition to the In Vitro Diagnostic Regulations (IVDR) which will be mandatory in 2022 for all manufacturers and distributors of all classes of medical diagnostics. 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 manufacturers and distributors to show compliance with the IVDR will be to have an externally audited certification to ISO 13485:2016, the Quality Management System for Medical Devices.

All SELFCheck products are CE marked according to the IVDD and assembled at our laboratories in North Wales according to a full ISO 13485:2016 quality management system, which is externally audited 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 delivery notes 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 are available from our Regulatory Manager.

JR Biomedical ISO13485 certification

JR Biomedical ISO13485 certification