Tighter controls on self-test kit companies

Tighter controls on self-test kit manufacturers and distributors are being implemented in the UK to improve public safety.

Our regulatory manager has over 20 years experience of diagnostic and medical device regulations, and explains the current, as well as future regulations for self-testing kits, highlighting the new standards that will need to be followed by the distributors, as well as the manufacturers.

All self test medical devices are already 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In Europe, since May 2022, these regulations have been replaced by the In Vitro Diagnostic Regulations (IVDR) (Regulation (EU) 2017/746), although tests approved under the IVDD are still allowed to be sold, pending the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 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 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, 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, MDC 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.

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 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:

  • diagnostic performance, risks, safety and reliability of the device meets the requirements for its intended use
  • instructions provided are easy to follow
  • all components included with the test have been validated, and are fit for purpose
  • device is designed and manufactured according to established international standards for medical devices (ISO13485:2016)
  • that the self-test can be easily used and interpreted by most laypersons
- and carry out annual on-site inspections of the manufacturing facilities, quality assurance system and product technical files.

    One of the key challenges of the new IVDR is 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.

    Undoubtedly, the new regulations will have a significant, albeit necessary, burden on manufacturer and distributor resources, both financial and the needed experience and expertise of employees. With the transition period for companies to meet the new regulatory requirements rapidly coming to a close, distributors and retailers should carefully consider which self-test manufacturers they partner with.

    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.

    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 IVDD/IVDR. All batches of products have LOT numbers to ensure full traceability of all components, and all delivery notes to trade customers contain details of lot numbers and expiry dates to ensure full traceability of kits throughout the supply chain.

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

    Find out more about SELFCHECK and the self-test range at selfcheckmedical.com

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